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The impact of acupuncture on IVF success rates: A randomised controlled trial

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The impact of acupuncture on IVF success rates: A
randomised controlled trial
K. Gillerman, A.
AQ1 Kulkarni, A. Shah, A. Gudi, Roy Homburg
Homerton Fertility Centre, Homerton
AQ2 University Hospital, Homerton Row, Hackney, London E9 6SR, UK
Abstract Background: Clinical trials to assess the benefits of acupuncture on in vitro fertilisation (IVF) treatment have
differed in study design, protocol, outcome measures and commercial bias. This heterogeneity has
precluded any firm conclusion regarding the efficacy, or otherwise, of acupuncture in this field. To address
this, 15 international acupuncturists with experience in treating women during IVF participated in Delphi
questionnaires and reached a consensus protocol to be used in future research. We were among the first to
adopt this newly agreed standard protocol. The aim of this study was to address whether the agreed
acupuncture consensus protocol is beneficial for IVF outcomes and may be offered to women undergoing
IVF. Methods: An randomised controlled trial, in which 157 women were randomised to receive either
acupuncture treatment three times in the treatment cycle in addition to our standard IVF protocol (n=79)
or no acupuncture treatment (n=78) in their first or second IVF cycle. They were between 23 and 43 years
with body mass index below 30. The study group (n=79) received acupuncture based on the Delphi
consensus protocol, between days 6 and 8 of ovarian stimulation, and twice on the day of embryo transfer,
before and after transfer. The IVF practitioner was blinded to the randomisation. The primary end point
was live birth. Results: Fifteen out of 79 women in the intervention group withdrew from the study
compared to 9/78 women from the control group (P<0.001). A per-protocol analysis revealed that the rate
of live births (27/64, 42% vs. 11/69, 15.94%, P=0.001) and positive pregnancy tests (34/64, 53% vs. 19/69,
27.53%, P=0.013) were significantly higher in the acupuncture group compared with the control group.
Conclusion: The results of this study imply that acupuncture may be offered as a possible method of
improving IVF outcome. This study followed a widely approved consensus protocol hoping to settle
disagreement in the literature and resolve previous disparity.
Trial Registration: ClinicalTrials NCT02683967.
Keywords: acupuncture, IVF, live birth, pregnancy rate
Address for correspondence: Roy Homburg, Homerton Fertility Centre, Homerton University Hospital,Homerton Row, Hackney, London E9 6SR, UK.
E-mail: royhomburg@gmail.com
BACKGROUND
Acupuncture is an ancient Chinese system of diagnosis
and treatment which is said to help a variety of conditions
including infertility. The delicate underlying mechanisms
of acupuncture have been explained and described in the
traditional Chinese medicine (TCM) language and in later
years its possible physiological background has been
repeatedly discussed.
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DOI:
10.4103/fsr.fsr_37_18
For reprints contact: reprints@medknow.com
How to cite this article: Gillerman K, Kulkarni A, Shah A, Gudi A, Homburg
R. The impact of acupuncture on IVF success rates: A randomised
controlled trial. Fertil Sci Res 2019;xx:xx.
Original Article
FSR_37_18R1_OA
© 2019 Fertility Science and Research | Published by Wolters Kluwer - Medknow 1
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There are increasing numbers of women reporting delays
in conceiving. For the past 10 years, the number of
assisted reproductive technology (ART) procedures has
increased significantly despite the often great personal
costs of ART. Over the last 2 decades, the use of
acupuncture in female infertility as an adjuvant to
conventional treatment in ART has been widely used.
In vitro fertilisation (IVF) is associated with significant
stress, which affects not only the outcome of the
treatment but also the general well-being of the couple
undergoing the procedure. There is a growing body of
evidence that acupuncture reduces the stress of IVF and
also improves its success rate.
[1,2]
The first clinical trial
which suggested the efficacy of acupuncture in improving
the clinical pregnancy rate in IVF was published in 1999.
[3]
In spite of dozens of clinical trials and reviews which
aimed to assess investigating the benefits of acupuncture
in various aspects of IVF, they all differ significantly in
their study design, acupuncture timing, protocol and final
outcome measures.
[4-6]
This lack of standardisation and
extreme heterogeneity prevent us reaching a conclusion
whether acupuncture is beneficial to IVF treatments, or
otherwise, and should be offered to women undergoing
IVF. For that reason, an adequately designed and
conducted randomised controlled trial (RCT) in
acupuncture is needed.
To address this,15 international acupuncturists experienced
in treating women with acupuncture during IVF
participated in three rounds of Delphi questionnaires
and reached a consensus for the use of TCM manual
acupuncture, with 86% agreement. Such consensus
offers guidance for further future research. We were
among the first to adopt and use the consensus protocol.
Recently, we were pleased to find out that a study
[7]
also
realized the importance of a standard protocol and used the
Delphi consensus in their trial. Our study presents a single-
centre RCT and its aims and objectives were to compare
acupuncture and IVF with IVF alone.
METHODS
The objective was to determine the clinical effectiveness
of acupuncture in improving live birth and pregnancy
rates in women undergoing IVF.
Study setting
This study was a single-centre RCT in a IVF centre of a
public university. As our study was a part of the patients
standard IVF care, the acupuncture sessions were
performed at the fertility centre so as to accommodate
the patient schedule.
Inclusion criteria
This included women under the age of 43 years with a
body mass index <30 undergoing their first or second
IVF cycle (with a fresh or frozen/thawed embryo
replacement).
Exclusion criteria
Women receiving donor eggs, body mass index 30 or
currently having acupuncture or any other form of
complementary and alternative medicine or having a
contraindication to acupuncture, such as those with
human immunodeficiency virus or hepatitis C positive,
were excluded.
PATIENTS
Eligible couples AQ3
were identified from the clinic database if
they fulfilled the inclusion criteria. Written informed
consent was obtained before randomisation. Ethical
approval was given by a local ethics committee (13/
LO/1356) and the trial was registered (NCT02683967).
Randomisation
Computer randomisation was performed by an
independent worker in blocks of 10 and distributed in
individual, consecutively numbered opaque envelopes
immediately before the start of the IVF cycle following
signed consent. Randomisation allocated couples to either
the acupuncture group to receive acupuncture three times
during the cycle of IVF (n=79) or to the control group in
which couples received only IVF but no acupuncture
(n=78) [Figure 1]. (To avoid disappointment, the patients
randomised to the control group were offered three free
acupuncture sessions to be used in a following IVF cycle
should they be unsuccessful.)
Power calculation
We anticipated a study participation rate of 50% of those
eligible. On the basis of a predicted live birth rate of 20%
in the controls and 40% in the acupuncture group, 79
patients were required in each group for a power of 80%
and a significance level of P<0.001.
Acupuncture protocol (based on Delphi consensus)
The first acupuncture treatment was manually administered
between days 6 and 8 of the stimulated cycle in a style
according to TCM. Chosen points during the stimulation
phase include core points ST29, CV4, CV6, SP6, SP10 and
up to five individualised additional points based on TCM
pattern differentiation. Most of the point locations were
mainly in the lower abdomen and some inthe legs and hands
(all performed bilaterally).
Gillerman, et al.: Acupuncture and IVF
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The duration of needling was approximately 25 minutes
using disposable stainless-steel acupuncture needles
(0.25 × 30 mm and 0.20 × 40 mm, Phoenix Medical,
Chelmsford, UK). The needles were inserted to a depth
varying from 10 ± 5 to 25 ± 5 mm at the acupoints
depending on the location and patients physical figure.
The practitioner (with 20 years of experience) maintained
Deqi which is a needling sensation interpreted as a flow of Qi
or the arrival of energy. This additional manual stimulation
was performed during the initial treatment on days 6 to 8
and during the pre-embryo transfer treatment. The second
and third treatments were performed on the day of embryo
transfer before and immediately after embryo transfer.
Points used for pre-transfer included SP8, SP10,LR3, ST29,
CV4 and one selected from HT7/PC6/YinTang
(depending on presentation of women). Points used
post-transfer included GV20, KD3, ST36, SP6 and PC6.
Points Shenmen (auricular) and Zigong (lower abdomen)
were used on the day of ET
AQ4 .
An acupuncture protocol describing the timing and
acupoints for each session is stored with all
acupuncture equipment so that the practitioner can
check and ensure consistency and accuracy during the
treatment. The checklist of the detailed information of the
procedure is attached in Appendix 1.
Acupuncture points
Points on the innervations area to the uterus and ovaries
in the abdominal muscles and in the leg were utilised as
well as fertility defined points thought to improve blood
circulation to the ovaries and the blood flow to the uterus
and hence thought to improve follicular and endometrial
responsiveness. Additional points were performed to
manage stress.
IVF protocols
The IVF protocol that was used was decided by the
attending clinician according to the departmental
guidelines. Basically, predicted low and normal
responders received long GnRH agonist protocols with
a starting FSH dose of 225 to 300 IU, whereas women
predicted to be high responders received a GnRH
antagonist protocol and a starting dose of FSH of 150
IU. Frozen/thawed embryos were replaced in an embryo
replacement cycle applying the use of estradiol 2 mg three
times daily and then vaginal progesterone starting the day
before replacement.
Analysis
The results were analysed on an intention-to-treat (ITT)
and per-protocol basis. The results were stratified
according to age, duration of infertility, type of cycle
Figure 1: Consort diagram.
Gillerman, et al.: Acupuncture and IVF
Fertility Science and Research | Vol xx | Issue xx | Month 2019 3
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(fresh or frozen), first or second IVF cycle and type of
infertility [Table 1]. All results were faithfully recorded on
a clinical research file designed especially for the purpose
and, when completed, transferred to SPSS (Statistical
Package for the Social Sciences
AQ5 ).
Statistical analysis
A Chi-squared test and t-test were used to determine the
differences between the acupuncture and control groups
and compare the two arms of the study for both an ITT
and per-protocol analysis. Chi-squared test was used for
the secondary end points wherever applicable. As the
dependent variables were categorical and not quantitative,
we used these analysis methods.
RESULTS
One hundred fifty-seven women were randomly allocated
to the intervention and the control groups. The
intervention group (n=79) was programmed for full
acupuncture treatment, whereas the control group
(n=78) did not receive any acupuncture treatment.
Either fresh or frozen/thawed embryo cycles were
included. Of the 79 women allocated to the
intervention group, 15 withdrew from the study (did
not do the acupuncture treatment at all, did not finish
the full treatment or had cancelled cycles), compared to
nine women from the control group [Figure 1]. The
number of dropouts in the acupuncture and the
Appendix 1: Checklist for items in STRICTA 2010
Item Detail Page
number
1. Acupuncture rationale(Explanations and
examples)
1a) Style of acupuncture (e.g. Traditional Chinese Medicine, Japanese, Korean, Western
medical, Five Element, ear acupuncture, etc)
3,6
1b) Reasoning for treatment provided, based on historical context, literature sources, and/or
consensus methods, with references where appropriate
3
1c) Extent to which treatment was varied 6
2. Details of needling(Explanations and
examples)
2a) Number of needle insertions per subject per session (mean and range where relevant) 6
2b) Names (or location if no standard name) of points used (uni/bilateral) 6,7
2c) Depth of insertion, based on a specified unit of measurement, or on a particular tissue
level
6
2d) Response sought (e.g. de qi or muscle twitch response) 6
2e) Needle stimulation (e.g. manual, electrical) 6
2f) Needle retention time 6
2g) Needle type (diameter, length, and manufacturer or material) 6
3. Treatment regimen(Explanations and
examples)
3a) Number of treatment sessions 6
3b) Frequency and duration of treatment sessions 6
4. Other components of treatment
(Explanations and examples)
4a) Details of other interventions administered to the acupuncture group (e.g. moxibustion,
cupping, herbs, exercises, lifestyle advice)
4b) Setting and context of treatment, including instructions to practitioners, and information
and explanations to patients
5
5. Practitioner background(Explanations and
examples)
5) Description of participating acupuncturists (qualification or professional affiliation, years in
acupuncture practice, other relevant experience)
6
6. Control or comparator interventions
(Explanations and examples)
6a) Rationale for the control or comparator in the context of the research question, with
sources that justify this choice
4
6b) Precise description of the control or comparator. If sham acupuncture or any other type
of acupuncture-like control is used, provide details as for Items 1 to 3 above.
5,7
Table 1: Basal data of acupuncture and control groups (per-protocol analysis)
AcupunctureN=64 ControlN=69 Significance
Mean (SD) Mean (SD) P
Age 32.88 (17.160) 34.93 (4.142) 0.337
Attempt 1.25 (0.508) 1.25 (0.715) 0.974
BMI 24.08 (3.375) 22.97 (15.976) 0.6
AFC 11.96 (23.481) 14.03 (14.03) 0.524
AMH (pmol/L) 18.04 (15.419) 16.40 (11.152) 0.488
No. of oocytes 11.75 (6.702) 10.06 (5.888) 0.124
EmbryosTransferred 1.56 (0.500) 1.67 (0.475) 0.221
%%P
Diagnosis 10.9% anovulation50% unexplained17.2% tubal6.2%
male1.6% endometriosis10.9% DOR
14.5% anovulation34.8% unexplained27.5% tubal15.9%
male0% endometriosis5.8% DOR
0.164
Protocol 44.1% agonist44.1% antagonist11.8% frozen 56.3% agonist35.2% antagonist8.5% frozen 0.349
Cycle 57.8% fresh42.2% frozen 62.3% fresh37.7 % frozen 0.596
AFC =antral follicle count, AMH =anti-Mullerian hormone, BMI =body mass index, DOR =diminished ovarian reserve.
Gillerman, et al.: Acupuncture and IVF
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control group was significantly different (X
2
(1) =12.67, P
<0.001). A set of Chi-square tests of independence was
performed for both ITT and per-protocol analysis. The
ITT analysis showed that rates of live birth 27/79
(34.60%) and positive pregnancy tests 35/79 (44.30%)
were significantly higher in the acupuncture group
compared to the control group in which rates of live
birth were 11/78 (14.10%) and rates of positive pregnancy
tests were 19/78 (24.36%), P<0.001.
After excluding the dropouts from each group, a set of
Chi-square tests of independence was performed to
examine any differences between the acupuncture and
the control groups (per protocol) regarding basal
parameters [Table 1] and rates of live births,
miscarriages and positive pregnancy tests [Table 2].
The rates of live births (X
2
(1) =11.207, P=0 .001)
and positive pregnancy tests (X
2
(1) =6.237, P=0.013)
were found to be significantly higher in the acupuncture
group compared to the control group [Table 2]. No
statistically significant difference was found between
the groups in the miscarriage rates. There were no
significant differences in the results of fresh and frozen
cycles.
Safety and adverse effects
Acupuncture was performed based on professional
standards of practice using disposable needles. There
were no adverse events; on the contrary, patients from
the acupuncture group filled a quality-of-life
questionnaire and reported better quality of life and
relief from the IVF symptoms after they had had the
acupuncture sessions.
DISCUSSION
In this study, we have shown that rates of live birth and
positive pregnancy tests are significantly higher following
a consensus acupuncture protocol for women undergoing
IVF treatment compared with a control group.
Acupuncture has been extensively studied to examine its
effect on live birth and pregnancy rates. However, debate
continues as different studies have used different
protocols and their outcomes are contradictory. Hence,
even with such extensive literature, no definitive
conclusions regarding the value of acupuncture for IVF
can be made. Analysing all studies so far with live birth as
the primary outcome, different timings of acupuncture
could be identified. One of the first RCTs was published
in 1999 suggesting that acupuncture improved the clinical
pregnancy rate in IVF.
[3]
In this study, 157 women
undergoing IVF were randomised to acupuncture or
controls before oocyte retrieval and a significantly
higher pregnancy rate was observed in the acupuncture
group. Since the RCT by Paulus et al.,
[8]
in which 25
minutes of acupuncture was performed before and after
embryo transfer with improved pregnancy rates in the
acupuncture group, several RCTs
[9-14]
and observational
studies
[15,16]
have been conducted to assess the effect of
acupuncture on live birth when applied around the time of
embryo transfer. However, the results have been highly
contradictory. While some RCTs showed improved
pregnancy rates,
[10,13,14]
others showed no difference
between the acupuncture and the control groups.
[9,11,12]
Another RCT divided women <40 years undergoing
IVF/intracytoplasmic sperm injection into two groups
and performed acupuncture in one group in three
sessions (each lasting for 25 minutes), with the first
session of 5 to 7 days before oocyte aspiration, second
session of 2 to 3 days before egg retrieval and third session
shortly after embryo transfer. The control group had no
intervention. The number of women recruited in this
preliminary study was limited; however, they concluded
that their results did not support a positive effect of
acupuncture on IVF.
[17]
Another negative RCT
randomised 228 women into an acupuncture group
where they received acupuncture on day 9 of ovarian
stimulation, before and after embryo transfer and a
placebo group with non-invasive sham acupuncture.
They could not show any significant difference in the
pregnancy rates between the two groups.
[18]
Assessing subjective outcome AQ6
like pain, anxiety and
general well-being, normally suggests the use of
appropriate placebo controls as otherwise the results
may be biased by the womens pre-judgement about
the effect of acupuncture. However, while assessing
objective outcomes like pregnancy rates, they are
unlikely to be affected by the womans expectations
and hence use of placebo control is questioned.
[19]
Furthermore, the method of non-penetrating needle
technique (Streitberger) cannot be considered as a
placebo as it has an acupressure effect, hence one must
remember that inertplacebos are not inert and the
validity of such trials is questionable.
[18]
After due
consideration and heeding the advice of Manheimer,
[19]
we decided that no placebo should be employed and a
control arm of no additional treatment would provide the
most reliable results.
Controversial evidence is available for the use of
acupuncture in the luteal phase of IVF. Although one
RCT with 225 women supported use of acupuncture in
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the luteal phase to improve pregnancy rate,
[20]
another
systematic review showed no benefits and suggested that
luteal phase acupuncture should not be offered until
further evidence is obtained.
[5]
Does acupuncture improve live birth in IVF?
A recent systematic review and meta-analysis of 24 trials
with 5807 participants has shown that although the
pooled clinical pregnancy rates were higher in the
acupuncture group, the live birth rates were not
significantly different than the control group.
[4]
However, the live birth rates were found to be higher
with acupuncture when the studies using Streitberger
controls were excluded. Further differences were seen
when different timings of acupuncture were analysed.
They concluded that acupuncture around the time of
oocyte aspiration or controlled ovarian hyper-stimulation
might be more effective in improving the pregnancy
outcome in IVF.
[4]
This meta-analysis was recently re-
evaluated in view of the marked heterogeneity. After
removing a few trials, no significant benefit of
acupuncture could be shown.
[21]
Also another
systematic review in 2012 analysed 17 trials and
showed no significant difference in clinical pregnancy,
biochemical pregnancy, ongoing pregnancy or live birth
rate between the acupuncture and the control groups.
[22]
Hence, the evidence regarding the efficacy of acupuncture
to improve clinical pregnancy rates is controversial. In
spite of 40 clinical trials and nine systematic reviews, the
debate still continues.
Problem with protocols used in different studies
As the effect of acupuncture differs along the menstrual
cycle, acupuncture applied at different time points
produces different results. Hence, different studies
using acupuncture at different time points are likely to
produce different effects and are not comparable. Even
slight alteration in the regimen might produce significant
changes in the results. Although some trials have used
acupuncture only around oocyte aspiration
[3]
or around
embryo transfer,
[9-14,23]
some have used it at different
time points throughout the IVF treatment including
ovarian stimulation, oocyte aspiration and embryo
transfer.
[17,18]
Significant differences are noted not
only in the timing but also in the acupuncture points
used in the different studies.Therefore, it has been agreed
that the quality of clinical acupuncture studies is
moderate, suffers from lack of standardisation and
extreme heterogeneity and that an adequately designed
and conducted RCT in acupuncture is needed.
[24]
For
that reason, this RCT is important as it is among the first
to follow such an appropriately designed protocol which
was achieved as an agreed consensus by experts in that
field. The importance of using this newly derived
consensus protocol is to be able to establish evidence
based data and settle disagreement in the literature to
resolve previous disparity. We believe this is the strength
of this RCT. A limitation of the present study is the
analysis of a relatively small group.
CONCLUSION
We have shown that using the acupuncture consensus
protocol in women undergoing IVF has a positive effect
on IVF outcome. This RCT is among the first studies to
follow the agreed protocol and has demonstrated the
positive effect of acupuncture on IVF success rates.
Therefore, we suggest that acupuncture may be offered
to women undergoing IVF treatments in an attempt to
improve their treatment outcome. More studies following
this consensus protocol are required in future to verify its
results.
Financial support and sponsorship
None.
Conflicts on interest
There are no conflicts of interest.
REFERENCES
1. de Lacey S, Smith CA, Paterson C. Building resilience: A preliminary
exploration of womens perceptions of the use of acupuncture as an
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Author Queries???
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AQ4: Please expand ET, GnRH, FSH.
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AQ6: Please check the sentence "Assessing subjective outcome ..." for clarity.
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Gillerman, et al.: Acupuncture and IVF
Fertility Science and Research | Vol xx | Issue xx | Month 2019 7
... 11 IVF success is assessed by measuring several outcomes, such as clinical pregnancy rate (CPR), ongoing pregnancy rate (OPR), and live-birth rate (LBR). 5,13,14 CPR is defined as a pregnancy diagnosed by ultrasound visualization of one or more gestational sacs or definite clinical signs of pregnancy. LBR is defined as the birth of a baby resulting from fertilization after 20 weeks of gestation, which, after birth shows signs of life, such as heart rate and pulsation of the umbilical cord or muscle movement, regardless of whether the umbilical cord has been broken or the placenta is still attached. ...
... According to several studies, the success of IVF is better when acupuncture is done not only during ET, but also from the follicular phase to the implantation phase. 14,15 This can be related to the mechanism of acupuncture for improving female infertility through modulation of the hypothalamic-pituitaryovarian (HPO) axis, estrogen regulation, and increased ß-endorphins to correct the imbalance of the endocrine system. Acupuncture can stimulate ovulation through modulation of the HPO axis in women with anovulatory infertility. ...
... There was a higher LBR and positive pregnancy rate in the acupuncture group, compared to the control group. 14 A randomized controlled trial study using the same consensus of acupuncture was conducted in 2018 by Smith et al. on 848 female subjects with the aim of seeing the efficacy of verum acupuncture on IVF compared to sham acupuncture. 15 In women undergoing IVF, verum acupuncture did not induce a different LBR compared to sham acupuncture. ...
Article
Full-text available
One treatment option for couples with infertility that enables the highest success rate is in vitro fertilization (IVF). With this technique, various causes of infertility can be overcome, whether they are caused by anatomical abnormalities in women or abnormalities of sexual dysfunction in men. Acupuncture, a nonpharmacologic therapy with minimal side-effects, according to various studies is be beneficial for increasing the success of IVF. There are several mechanisms of acupuncture related to this, such as: (1) modulating neuroendocrine factors; (2) increasing blood flow to the uterus and ovaries; (3) modulating immune factors; and (4) reducing stress, anxiety, and depression. Because acupuncture does not have bad side-effects, it is an adjuvant therapy that can be performed at each stage of the IVF procedure to increase the chances of successful IVF.
... Seven of the selected publications were carried out in European countries: 3 in Sweden [5,12,14]; 1 in Denmark [13], 1 in Austria [15], and 2 in UK [34,42]. Three trials were completed in the USA [16,18,23]. ...
... Twenty-four trials were performed primarily to assess the effect of acupuncture on IVF outcomes [12,[16][17][18][19][21][22][23][25][26][27][28][29][30][31][32][33][34][35][36][38][39][40][41], and among these 24 trials seven of them also evaluated the effect on the oocyte/embryo quality [17,19,25,28,30,31,39], seven on endometrial receptivity [26,27,32,33,36,38,41] and one on ovarian reserve [29]. Besides the secondary IVF outcomes, the main objective in six trials was to assess the pain-relieving effects of acupuncture [5,[12][13][14][15]37], and in the remaining two trials to assess the anxiety-relieving effect of acupuncture [20,24]. ...
... Eight trials used EA [5,12,13,17,19,25,28,43], 16 trials used TA [16,18,[20][21][22][23]27,[31][32][33][34][35][36]38,39,41], three trials used AA [15,24,37] and two of these trials used both AA and EA [15,37], and four trials used TEAS [26,29,30,40]. Six trials [15,22,24,26,29,40] used sham or placebo intervention as the control group, while others used no acupuncture interventions as control. ...
Article
Full-text available
The present systematic review is designed to summarize the evidence concerning the effect of acupuncture on pregnancy outcomes in vitro fertilization with embryo transfer (IVF-ET). We searched MEDLINE, the Wanfang Database, the China Academic Journal Electronic Full-text Database in the China National Knowledge Infrastructure, and the Index to Chinese Periodical Literature. Randomized controlled trials with intervention groups using acupuncture and control groups consisting of no acupuncture or sham (placebo) acupuncture in IVF-ET treatment were selected. Study characteristics were examined from these studies and an intention-to-treat approach was used to extract outcome data from each study. In total, 31 articles including 4450 women passed our selection criteria. The legitimacy, characteristics, and IVF outcomes of the included trials were summarized. Additional Traditional Chinese Medicine (TCM) theory-based, standardized, large-size, randomized, and multicenter trials are necessary prior to any conclusions being drawn on whether TCM can improve IVF outcomes.
... Genital tuberculosis has been reported for significant morbidity with varying incidence rates. It may lead to infertility in females as a consequence of damaged to the fallopian tubes and endometrium [33]. ...
Article
Full-text available
Tuberculosis is a global health challenge due to its spreading potential. The Kingdom of Saudi Arabia (KSA) faces a challenge in the spread of tuberculosis from migrant workers, but the foremost threat is the huge number of pilgrims who travel to visit sacred sites of the Islamic world located in the holy cities of Makkah and Al Madina. Pilgrims visit throughout the year but especially in the months of Ramadan and Zul-Hijah. The rise of resistance in Mycobacterium tuberculosis is an established global phenomenon that makes such large congregations likely hotspots in the dissemination and spread of disease at a global level. Although very stringent and effective measures exist, the threat remains due to the ever-changing dynamics of this highly pathogenic disease. This overview primarily highlights the current public health challenges posed by this disease to the Saudi health system, which needs to be highlighted not only to the concerned authorities of KSA, but also to the concerned global quarters since the pilgrims and migrants come from all parts of the world with a majority coming from high tuberculosis-burdened countries.
Article
Background: Women undergoing in vitro fertilization and embryo transfer (IVF-ET) often utilize acupuncture to enhance pregnancy outcomes. Yet, the optimal timing for acupuncture sessions and the relationship between dosage and effect remain uncertain. Objectives: To investigate the impact of the timing and dosage of acupuncture on pregnancy outcomes, drawing on existing research. Methods: A comprehensive search of eight databases was conducted from their inception to January 14th, 2023, without restrictions on language. Only randomized controlled trials comparing acupuncture with either sham acupuncture or no adjuvant treatment were selected for inclusion. This meta-analysis assessed the efficacy of acupuncture in IVF-ET, analyzing the influence of varied timing and dosage on pregnancy outcomes. Subgroup analyses were undertaken to address any heterogeneity across the studies. Results: A total of 38 RCTs involving 5,991 participants were analyzed. In infertile women undergoing IVF fresh cycles, acupuncture performed during controlled ovarian hyperstimulation (COH) significantly increased the clinical pregnancy rate (CPR) (relative risk [RR] = 1.33, 95% confidence interval [CI]: 1.07-1.65, p = 0.01), whereas acupuncture administered either before COH or on the day of ET did not demonstrate reproductive benefits. Regarding frozen cycles, acupuncture before freeze-thaw embryo transfer (FET) significantly enhanced the CPR (RR = 1.71, 95% CI: 1.36-2.16, p < 0.00001) and live birth rate (LBR) (RR = 2.40, 95% CI: 1.20-4.79, p = 0.01). Improvements in CPR were observed across all dosage groups, but only the high-dosage group showed a significant increase in LBR (RR = 1.75, 95% CI: 1.05-2.92, p = 0.03). Conclusions: Timing and dosage of acupuncture are crucial factors affecting pregnancy outcomes in IVF-ET. For women undergoing IVF fresh cycles, acupuncture during COH yielded more significant reproductive benefits. In addition, acupuncture before freeze-thaw embryo transfer (FET) was associated with improved pregnancy outcomes in frozen cycles. Furthermore, higher dosages of acupuncture were linked to more favorable outcomes.
Article
Assisted reproductive technologies, particularly in vitro fertilization, have become integral in addressing infertility concerns. Despite advancements in IVF, challenges persist, leading to exploration of adjunctive therapies. Acupuncture has gained interest as a complementary intervention for individuals undergoing in vitro fertilization. This narrative review synthesises existing literature, critically evaluating methodologies and outcomes of studies investigating acupuncture's role in IVF. The review aimed to provide a nuanced perspective on acupuncture's effectiveness in assisted reproduction, focusing on pregnancy rates, implantation success, and live birth rates. A comprehensive literature search was conducted on databases such as PubMed and Embase, limited to English studies published in the last 10 years. A narrative synthesis approach was employed to summarize findings, addressing variations in study designs and reported outcomes. The results encompass ten selected studies, employing diverse participant numbers and research designs. Manual acupuncture was the predominant technique, with one study utilising electroacupuncture and another incorporating moxibustion. This diversity necessitates a thorough examination to draw meaningful conclusions regarding acupuncture's impact on IVF outcomes. The critical review contributes to the ongoing discourse on integrating traditional and modern therapeutic modalities, fostering a comprehensive understanding of acupuncture's potential synergy with IVF for successful pregnancies.
Article
Background The effects of acupuncture on in-vitro fertilization outcomes remain controversial. This study aimed to perform a meta-analysis to assess the effectiveness of acupuncture as an adjuvant therapy to embryo transfer compared to sham-controls or no adjuvant therapy controls on improving pregnancy outcomes in women undergoing in-vitro fertilization. Methods A systematic literature search up to January 2021 was performed and 29 studies included 6623 individuals undergoing in-vitro fertilization at the baseline of the study; 3091 of them were using acupuncture as an adjuvant therapy to embryo transfer, 1559 of them were using sham-controls, and 1441 of them were using no adjuvant therapy controls. They reported a comparison between the effectiveness of acupuncture as an adjuvant therapy to embryo transfer compared to sham-controls or no adjuvant therapy controls on improving pregnancy outcomes in women undergoing in-vitro fertilization. Odds ratio (OR) with 95% confidence intervals (CIs) were calculated assessing the effectiveness of acupuncture as an adjuvant therapy to embryo transfer compared to sham-controls or no adjuvant therapy controls using the dichotomous method with a random or fixed-effect model. Results Significantly higher outcomes with acupuncture were observed in biochemical pregnancy (OR, 1.98; 95% CI, 1.55–2.53, p < 0.001); clinical pregnancy (OR, 1.70; 95% CI, 1.46–1.98, p < 0.001); ongoing pregnancy (OR, 1.78; 95% CI, 1.41–2.26, p < 0.001); and live birth (OR, 1.58; 95% CI, 1.15–2.18, p = 0.005) compared to no adjuvant therapy controls. However, no significant difference were found between acupuncture and no adjuvant therapy controls in miscarriage (OR, 0.96; 95% CI, 0.48–1.92, p = 0.91). No significant difference was observed with acupuncture in biochemical pregnancy (OR, 1.16; 95% CI, 0.65–2.08, p = 0.62); clinical pregnancy (OR, 1.13; 95% CI, 0.83–1.54, p = 0.43); ongoing pregnancy (OR, 1.04; 95% CI, 0.66–1.62, p = 0.87); live birth (OR, 1.02; 95% CI, 0.73–1.42, p = 0.90), and miscarriage (OR, 1.16; 95% CI, 0.86–1.55, p = 0.34) compared to sham-controls. Conclusions Using acupuncture as an adjuvant therapy to embryo transfer may improve the biochemical pregnancy, clinical pregnancy, ongoing pregnancy, and live birth outcomes compared to no adjuvant therapy controls. However, no significant difference was found between acupuncture as an adjuvant therapy to embryo transfer and sham-controls in any of the measured outcomes. This relationship forces us to recommend the use of acupuncture as adjuvant therapy in women undergoing in-vitro fertilization and inquire further studies comparing acupuncture and sham-controls to reach the best procedure.
Article
El presente estudio es una revisión sistemática de los trabajos científicos sobre la eficacia y seguridad de la acupuntura en las condiciones clinicas más frecuentes en obstetricia. Se incluyeron ensayos clinicos, revisiones sistemáticas y meta-análisis disponibles hasta septiembre 2020. La fuerza de las evidencias según la calidad de los trabajos, para la eficacia de la acupuntura se ubicó en tres grupos. Los de las náuseas y vómitos del embarazo, dolor de espalda y dolor de parto se ubican en el primer grupo. Para las otras condiciones hace falta más investigaciones o estudios mejor diseñados para establecer conclusiones definitivas. En cuanto a la seguridad, se encontró que la calidad de los reportes de los efectos adversos de la acupuntura es pobre, aunque la incidencia de los mismos parece ser baja y de gravedad leve a moderada comparada con los tratamientos convencionales.
Article
Full-text available
Background: The variability of published acupuncture protocols for patients undergoing In-Vitro Fertilization (IVF) complicates the interpretation of data and hinders our understanding of acupuncture's impact. In 2012, an acupuncture treatment protocol developed by a Delphi consensus process was published to describe the parameters of best practice acupuncture for Assisted Reproductive Technology and future research. However, there has been no clinical trial utilizing this protocol to assess the effects of acupuncture. This study aims to assess the implementation of Dephi consensus acupuncture protocol and to examine the impact of acupuncture on stress and uterine and ovarian blood flow among women between ages 21-42 years seeking IVF. Methods/design: This study is a one site prospective, two-arm randomized controlled non-blind clinical trial conducted in a medical school-affiliated fertility center . Participants will be randomized 1:1 into either the acupuncture group or the standard of care (no acupuncture) group using computer generated tables. Both groups will have 3 regular clinical visits as their standard IVF care during an approximately 2 to 3 weeks window. Women who are randomized into the acupuncture group would receive three sessions based on the Delphi consensus acupuncture protocol in addition to the standard care. The first treatment will be administered between days 6 to 8 of the stimulated IVF cycle. The second session will be performed on the day of embryo transfer at least 1 h prior to the transfer. The third session will be performed within 48 h post-embryo transfer. Participants will be followed for their pregnancy test and pregnancy outcome when applicable. The outcomes stress and blood flow will be measured by a validated perceived stress scale and vasoactive molecules, respectively. Discussion: Although recruitment and scheduling could be challenging at times, the Delphi consensus acupuncture protocol was implemented as planned and well-accepted by the patients. Because of the time-specified sessions around patients' IVF cycle, it is highly recommended to have on-site study acupuncturist(s) to accommodate the schedule. Trial registration: ClinicalTrials NCT02591186 registered on October 7, 2015.
Article
Full-text available
Assisted reproductive technologies (ART) are increasingly utilised for resolving difficulties conceiving. These technologies are expensive to both the public purse and the individual consumers. Acupuncture is widely used as an adjunct to ART with indications that it may assist reducing the time to conception and increasing live birth rates. Heterogeneity is high between treatment protocols. The aim of this study was to examine what fertility acupuncturists consider key components of best practice acupuncture during an ART cycle, and to establish an acupuncture protocol by consensus. Fifteen international acupuncturists with extensive experience treating women during ART interventions participated in 3 rounds of Delphi questionnaires. The first round focused on identifying the parameters of acupuncture treatment as adjunct to ART, the second round evaluated statements derived from the earlier round, and the third evaluated specific parameters for a proposed trial protocol. Consensus was defined as greater than 80% agreement. Significant agreement was achieved on the parameters of best practice acupuncture, including an acupuncture protocol suitable for future research. Study participants confirmed the importance of needling aspects relating to the dose of acupuncture, the therapeutic relationship, tailoring treatment to the individual, and the role of co-interventions. From two rounds of the Delphi a consensus was achieved on seven treatment parameters for the design of the acupuncture treatment to be used in a clinical trial of acupuncture as an adjunct to ART. The treatment protocol includes the use of the traditional Chinese medicine acupuncture, use of manual acupuncture, a first treatment administered between day 6-8 of the stimulated ART cycle which is individualised to the participant, two treatments will be administered on the day of embryo transfer, and will include points SP8, SP10, LR3, ST29, CV4, and post transfer include: GV20, KD3, ST36, SP6, and PC6. Auricular points Shenmen and Zigong will be used. Practitioner intent or yi will be addressed in the treatment protocol. Despite a lack of homogeneity in the research and clinical literature on ART and acupuncture, a consensus amongst experts on key components of a best practice treatment protocol was possible. Such consensus offers guidance for further research.
Article
Women's choice to delay fertility due to various reasons is making subfertility a growing problem and increased use of IVF as a last resort. Despite advances in the technology, IVF success remains low, especially in older women. Hence, many of these women need to undergo several cycles of IVF and are faced with unprecedented anxiety and frustration. In desperation, they resort to anything that might increase the success of their IVF treatment. Acupuncture has gained popularity among the various complementary medicines available and many go privately to have acupuncture while undergoing IVF. Since 1999, in spite of multiple trials and systematic reviews, the beneficial effect of acupuncture in improving the success of IVF remains unproven and debatable. As clinicians, we face the dilemma of what to suggest to our patients when asked about having acupuncture during IVF, given that different meta-analyses have come to different conclusions. Hence, this review is conducted with the aim to summarise the available literature and provide a better insight into this complex and controversial topic.
Article
The most recent meta-analysis appearing in Fertility and Sterility on acupuncture was reevaluated in view of the marked heterogeneity of interventions, controls, data analysis, and timing of interventions in the trials that were included. After removing some of the trials and data based on more rigorous standards for a high quality meta-analysis, a significant benefit of the intervention could no longer be shown. When studies with and without placebo controls were analyzed separately, a placebo effect was suggested. Individual trials with a confidence limit below unity emphasized the potential for a detrimental impact on outcomes, which should be considered both in using acupuncture clinically as an adjunct for IVF and in design of future trials. Much more data that includes a placebo control will be required before a conclusion can be made that acupuncture has a true treatment effect on IVF outcomes. However, unless the timing and method of the acupuncture are standardized, practitioners will still have difficulty being sure that their particular method will help beyond the apparent benefit provided by a placebo.
Article
The objective of this article was to conduct a systematic review with meta-analysis of the trials of acupuncture during in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment on the outcomes of clinical pregnancy, biochemical pregnancy, ongoing pregnancy, implantation rate, live birth, and miscarriage. The search was conducted by using MEDLINE(®), SCISEARCH, the Cochrane Menstrual Disorders and Subfertility Group trials register, AMED, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Wanfang Database, China Academic Journal Electronic full text Database in China National Knowledge Infrastructure, Index to Chinese Periodical Literature, ISI Proceedings for conference abstracts, and ISRCTN Register and Meta-register for randomized controlled trials. Study selection, quality appraisal, and data extraction were performed independently and in duplicate. The measures of treatment effect were the pooled relative risks (RR) of achieving clinical pregnancy, biochemical pregnancy, ongoing pregnancy, implantation rate, live birth, or miscarriage for women in the acupuncture group compared with women in the control group. Using the random-effects model, pooling of the effect estimates from all of the 17 trials showed no significant difference in the clinical pregnancy outcome between the acupuncture and the control groups (RR=1.09, 95% confidence interval (CI) 0.94-1.26, p=0.25). No significant differences in the biochemical pregnancy, ongoing pregnancy, implantation rate, live birth, or miscarriage outcomes were found between the acupuncture and the control groups (biochemical pregnancy: RR=1.01, 95% CI 0.84-1.20, p=0.95; ongoing pregnancy: RR=1.20, 95% CI 0.93-1.56, p=0.16; implantation rate: RR=1.22, 95% CI 0.93-1.62, p=0.16; live birth: RR=1.42, 95% CI 0.92-2.20, p=0.11; miscarriage outcomes: RR=0.94, 95% CI 0.67-1.33, p=0.74). No significant benefits of acupuncture are found to improve the outcomes of IVF or ICSI.
Article
To evaluate the effect of acupuncture on in vitro fertilization (IVF) outcomes. Systematic review and meta-analysis. Women undergoing IVF in randomized controlled trials (RCTs) who were evaluated for the effects of acupuncture on IVF outcomes. Not applicable. The intervention groups used manual, electrical, and laser acupuncture techniques. The control groups consisted of no, sham, and placebo acupuncture. The major outcomes were clinical pregnancy rate (CPR) and live birth rate (LBR). Heterogeneity of the therapeutic effect was evaluated with a forest plot analysis. Publication bias was assessed by a funnel plot analysis. Twenty-four trials (a total of 5,807 participants) were included in this review. There were no significant publication biases for most of the comparisons among these studies. The pooled CPR (23 studies) from all of the acupuncture groups was significantly greater than that from all of the control groups, whereas the LBR (6 studies) was not significantly different between the two groups. The results were different when the type of control was examined in a sensitivity analysis. The CPR and LBR differences between the acupuncture and control groups were more obvious when the studies using the Streitberger control were ignored. Similarly, if the underlying effects of the Streitberger control were excluded, the LBR results tended to be significant when the acupuncture was performed around the time of oocyte aspiration or controlled ovarian hyperstimulation. Acupuncture improves CPR and LBR among women undergoing IVF based on the results of studies that do not include the Streitberger control. The Streitberger control may not be an inactive control. More positive effects from using acupuncture in IVF can be expected if an appropriate control and more reasonable acupuncture programs are used.
Article
To examine the theoretical and methodologic rationales for the use of sham acupuncture controls in trials of adjuvant acupuncture for in vitro fertilization (IVF), and to identify the drawbacks of using a sham acupuncture control that may have its own effects on the pregnancy outcome. Acupuncture has typically been tested in trials that evaluate subjective, patient-reported outcomes such as pain. Ratings of pain and similar subjective states can be strongly influenced by respondents' prejudgments, preferences, and expectations about treatment benefits. Therefore, controlling for these expectations or "placebo effects" by using a sham acupuncture control group is critically important in trials of acupuncture for pain-related conditions. This need for sham acupuncture controls in trials of acupuncture for pain-related conditions may have led to the belief that sham acupuncture is always the most "rigorous" control, and that it should therefore be used for all acupuncture trials, including trials of adjuvant acupuncture for IVF. In trials of adjuvant acupuncture for IVF, the outcome is pregnancy, which is entirely objective and unlikely to be affected by a patient's expectations of a benefit of acupuncture. Because it seems unlikely that an IVF patient's knowledge of whether she was receiving adjuvant acupuncture would affect her ability to become pregnant from IVF, using sham acupuncture to control for expectation/placebo effects seems unnecessary in this context. Even if adjuvant acupuncture were to increase IVF success rates only through a psychosomatic effect mechanism, such as by reducing stress, this stress-reduction effect would be integral to the working mechanism by which adjuvant acupuncture increases IVF pregnancy rates; therefore, it seems inappropriate to control for and separate out any such stress-reduction effect by using a sham control. Because of the risk that the sham is not an inert placebo but rather an active treatment that may affect the pregnancy outcome, using sham acupuncture as the control may unnecessarily confuse rather than clarify the interpretation of the effects of IVF adjuvant acupuncture. Using both theoretical concerns and epidemiologic evidence, researchers should carefully weigh the benefits and drawbacks of using sham acupuncture to blind patients in adjuvant acupuncture for IVF trials, and should question, rather than automatically accept, whether "placebo effects" are an important risk of bias in this context.