ArticlePDF Available

Cohort Comparison of Two Fertility Awareness Methods of Family Planning

Authors:

Abstract

To determine if an electronic hormonal fertility monitor aided method (EHFM) of family planning is more effective than a cervical mucus only method (CMM) in helping couples to avoid pregnancy. Six hundred twenty-eight women were taught how to avoid pregnancy with either the EHFM (n=313) or the CMM (n = 315). Both methods involved standardized group teaching and individual follow-up. All pregnancies were reviewed and classified by health professionals. Correct use and total unintended pregnancy rates over 12 months of use were determined by survival analysis. Comparisons of unintended pregnancies between the 2 methods were made by use of the Fisher exact test. There were a total of 28 unintended pregnancies with the EFHM and 41 with the CMM. The 12-month correct use pregnancy rate of the monitor-aided method was 2.0%, and the total pregnancy rate was 12.0%. In comparison, the 12-month correct use pregnancy rate of the CMM was 3.0%, and the total pregnancy rate was 23.0%. There was a significant difference in total pregnancies between the 2 groups (p<0.05). EFHM is more effective than CMM. Further research is needed to verify the results.
165
OBJECTIVE: To determine if an electronic hormonal fer-
tility monitor aided method (EHFM) of family planning
is more effective than a cervical mucus only method
(CMM) in helping couples to
avoid pregnancy.
STUDY DESIGN: Six hun-
dred twenty-eight women
were taught how to avoid
pregnancy with either the
EHFM (n = 313) or the
CMM (n = 315). Both meth-
ods involved standardized
group teaching and individ-
ual follow-up. All pregnan-
cies were reviewed and clas-
sified by health professionals. Correct use and total
unintended pregnancy rates over 12 months of use were
determined by survival analysis. Comparisons of unin-
tended pregnancies between the 2 methods were made by
use of the Fisher exact test.
RESULTS: There were a total of 28 unintended preg-
nancies with the EFHM and 41 with the CMM. The 12-
month correct use pregnancy rate of the monitor-aided
method was 2.0%, and the total pregnancy rate was
12.0%. In comparison, the 12-month correct use preg-
nancy rate of the CMM was 3.0%, and the total preg-
nancy rate was 23.0%. There was a significant difference
in total pregnancies between the 2 groups (p < 0.05).
CONCLUSION: EFHM is more effective than CMM.
Further research is needed to verify the results. (J Re-
prod Med 2009;54:165–170)
Keywords: family plan-
ning, fertility, fertility
monitoring, natural fami-
ly planning.
Unintended pregnancies
are a major health prob-
lem for women in devel-
oped and developing
countries.
1-3
In the United
States approximately 50%
of all pregnancies are unintended, and almost half
of these result in abortion.
4
Many of these unin-
tended pregnancies are due to discontinuation of
contraceptive methods, and, in turn, discontinua-
tion is often due to dissatisfaction with contracep-
tive methods—and in particular with hormonal
side effects.
2
In contrast, fertility awareness meth-
ods (FAMs) of family planning are free of side ef-
fects and have very low discontinuation rates when
compared to other birth control methods.
2
Studies consistently show that women prefer to
have effective, safe, easy-to-use and convenient
methods of family planning.
5-7
Although FAMs are
From Marquette University College of Nursing, Milwaukee, Wisconsin; Saint Louis University School of Nursing, St. Louis, Missouri;
and Dr. Raviele’s private gynecology practice, Atlanta, Georgia.
Presented at the European Congress on Fertility Awareness–Based Methods, Antwerp, September 5–6, 2008.
Address correspondence to: Richard J. Fehring, Ph.D., R.N., Marquette University College of Nursing, P.O. Box 1881, Milwaukee, WI
52301-1881 (richard.fehring@marquette.edu).
Financial Disclosure: The authors have no connection to any companies or products mentioned in this article.
Cohort Comparison of Two Fertility Awareness
Methods of Family Planning
Richard J. Fehring, Ph.D., R.N., Mary Schneider, M.S.N., A.P.R.N.,
Mary Lee Barron, Ph.D., A.P.R.N., and Kathleen Raviele, M.D.
The Journal of Reproductive Medicine
®
0024-7758/09/5403-0165/$18.00/0 © Journal of Reproductive Medicine
®
, Inc.
The Journal of Reproductive Medicine
®
An EHFM aided method of FAM that
utilizes a double check for the
beginning and end of the estimated
fertile phase is more effective in
helping couples to avoid pregnancy
than a CMM only FAM.
DO NOT DUPLICATE
© Copyrighted Material
free of side effects, they are often ineffective and
complex to learn and use.
8-10
Efforts have occurred
over the past 10 years to simplify the teaching, use
and efficacy of FAMs.
6,8,11,12
These efforts include
developing low-tech, calendar-based methods; sim-
plifying instructions; and developing accurate bio-
logic markers of fertility.
6,8,11,14-17
A new high-tech electronic device to monitor fer-
tility has been developed to help women determine
their fertile window with ease, convenience and ac-
curacy.
7,18
This high-tech electronic hormonal fer-
tility monitor (EHFM) called the ClearBlue Easy
Fertility Monitor (Inverness Medical Innovations,
Waltham, Massachusetts), measures urinary me-
tabolites of estrogen and luteinizing hormone (LH)
and provides the user with a daily indication of
“low,” “high” and “peak” fertility. A recent ran-
domized, controlled trial of the EHFM showed a
significant increase in cumulative pregnancy rates
among women trying to achieve a pregnancy in
comparison to a control group of women using ran-
dom (rather than focused) acts of intercourse.
19
Fur-
thermore, recent cohort studies demonstrated that
the EHFM was effective when used as an aid to
monitoring fertility to avoid pregnancy and had
high satisfaction with use.
7,20-22
However, there
have been no comparison studies of EHFM FAMs
with FAMs that utilize a single, traditional biologic
marker of fertility (i.e., the ovulation method and
cervical mucus monitoring ([CMM]).
The purpose of this study was to compare the ef-
ficacy of 2 FAMs (an EHFM aided method and
CMM only method) in aiding couples in avoiding
pregnancy. The CMM method is based upon
changes in externally self-detected cervical vaginal
mucus. Cervical mucus changes in response to ris-
ing levels of estrogen produced by a dominant de-
veloping follicle. The mucus at first is scant, thick
and cloudy. However, as estrogen rises, the mucus
becomes thin, clear, watery, perfuse and slippery.
The clear, slippery mucus coincides closely with
the time of ovulation.
17,23
After ovulation the mu-
cus rapidly becomes thick and cloudy due to the ris-
ing levels of progesterone produced by the corpus
luteum.
The EHFM aided method utilizes externally self-
detected changes in cervical mucus to estimate the
beginning, peak and end of the fertile phase of the
menstrual cycle and the EHFM as a second indica-
tor. The EHFM measures a threshold level of the
rise of estrogen that occurs about 5 days before ovu-
lation and a threshold level of the LH rise that oc-
curs about 24 hours before ovulation. The specific
research hypothesis was that couples who are
taught and use an EHFM aided FAM will have
fewer unintended pregnancies over a 12-month pe-
riod as compared to couples who use a CMM only
FAM.
Materials and Methods
A retrospective cohort comparison was used to de-
termine the relative efficacy of an EHFM aided
FAM and a CMM only FAM in avoiding pregnancy
and to determine if the EHFM aided method was
more effective than the CMM method. Although
the study was retrospective, the participants in the
study were taught the methods prospectively with
standardized teaching methods and with a stan-
dardized means of assessing pregnancy outcomes.
The participants in this study were all 843 women
who sought to learn how to use a method of FAM to
either avoid or achieve a pregnancy at 4 clinical
sites (Saint Augustine, Florida; Atlanta, Georgia; St.
Louis, Missouri; and Milwaukee, Wisconsin). Of
these 843 women, 638 sought FAMs to avoid preg-
nancy. Three hundred fifteen of the women were
taught an EHFM aided method of family planning,
and 318 were taught a CMM only FAM of family
planning. All of the providers at the 4 clinical sites
were health professionals (physicians and profes-
sional nurses) who had extensive training in each
method. The CMM only FAM participants included
all couples who were taught the CMM only method
at the Atlanta and Milwaukee clinical sites. The
EHFM aided FAM participants were all of the cou-
ples who sought services from the 4 clinical sites.
The inclusion criteria for the study were women
between 18 and 44 years with no known infertility
problems. Participants were not excluded if they re-
cently (within 3 months) discontinued hormonal
oral contraception. The participants were taught 1
of the 2 FAMs between the years 1985 and 2006. Of
the 628 participants, 295 participated either in a
prospective clinical efficacy study of an EHFM
aided FAM
20
or a retrospective efficacy study,
23
and 240 participated in an efficacy study of the
CMM only method.
24
The CMM only participants
from the 1994 study were reentered into a new data
set, and all pregnancies were reevaluated as to
whether a pregnancy was intended or not. The 1994
study did not analyze pregnancy rates in the same
manner as the current study.
Both FAMs included a standardized, 1-hour in-
troductory session, monthly individual follow-up
166 The Journal of Reproductive Medicine
®
DO NOT DUPLICATE
© Copyrighted Material
sessions for the first 3 months of use and follow-up
sessions until the woman and her partner were
assessed to be autonomous in the use of the given
method. Couples were taught to track and chart
natural fertility indicators that included self-
observation of cervical mucus alone or cervical
mucus with information from an electronic fertility
monitor that measured urinary metabolites of es-
trogen and LH.
The EHFM has been independently evaluated to
be highly accurate in comparison with serum levels
of estrogen and LH.
15,16
Furthermore, ultrasound
tracking of the dominant follicle to estimate the day
of ovulation among women using the hormonal
monitor has shown that ovulation occurs over 97%
of the time during the peak reading of the monitor
or the proceeding high reading day.
15
However, the
monitor does not always indicate high fertility at
the beginning of the actual fertile phase of the men-
strual cycle.
13
Therefore, to use the monitor another
marker of fertility needs to be utilized to estimate
the beginning of the fertile phase.
For the CMM only FAM users, the beginning of
the fertile phase was the presence of self- assessed
cervical mucus; for the EHFM users the beginning
of the fertile window was either the presence of cer-
vical mucus or the high reading on the monitor,
whichever came first. For the CMM only method,
the end of the estimated fertile phase was the last
day of the peak-type mucus plus a count of 3 full
days, and for the EHFM users the end of the fertile
phase was either the last day of peak-type mucus or
the last peak reading on the monitor followed by 3
full days, whichever occurred last.
All pregnancies were reviewed and classified by
health professionals by use of an extensive in-
person pregnancy evaluation to determine if the
pregnancy was due to method or user error and
whether the pregnancy was intended or not. Infor-
mation from the fertility charts and pregnancy eval-
uations were submitted to the principal investiga-
tor without identifying information. Data were
entered from the charts into a data file. The study
received human compliance approval from the
Marquette University office of research compliance.
Correct use and total unintended pregnancy
rates, over 12 months of use, were determined by
survival analysis (Kaplan-Meier) with SPSS 15 soft-
ware (SPSS, Inc., Chicago, Illinois). Survival rates
were determined for the total data set (total N =628,
n=313 for the EHFM group and n=315 for the
CMM group) with all reproductive categorizes and
with a smaller data set that comprised only those
women with regular length menstrual cycles (total
N=413; n=213 for the EHFM group and n=200 for
the CMM group). Comparisons of unintended
pregnancies between the 2 FAMs were made by use
of the Fisher exact test with a significant probability
set at 0.05.
Results
Participants
The mean age of the 313 participants in the EHFM
group was 28.4 years (SD=5.9) and for the 315 par-
ticipants in the CMM group, 28.7 (SD =5.8). The age
of the male partners in the EHFM group was 30.3
(SD=6.1) and in the CMM group, 30.7 (SD=6.0).
There was a significant difference in the mean age
of both the men and women between these 2
groups. Most of the women participants (86% in the
EHFM group and 91% in the CMM group) were
white Americans; 7% were Hispanic Americans in
the EHFM group and 2% in the CMM group. Only
2% in the EHFM group were African Americans
and 3% in the CMM group. Most participants were
Catholic (86% EHFM and 82% CMM) followed by
10% and 12% Protestant, respectively. There were
no significant differences in the number of years
married (6.8 vs. 5.0), the number of pregnancies (2.1
vs. 1.9) and the number of children (1.8 vs. 1.4).
There was no difference in the mean ages of the
females and males in the reduced regular menstru-
al cycle group. The mean age was 28.4 for the 214 fe-
males in the EHFM group and 28.7 for the 200 fe-
males in the CMM group (30.3 vs. 30.7, respectively,
for the males).
Overall Unintended Pregnancy Rates
Overall there were 68 unintended pregnancies
among both methods, 27 in the EHFM group and 41
in the CMM group. The 12-month correct use unin-
tended pregnancy rate for the EHFM group was
2.0%—i.e., a survival rate of 0.980 (95% CI 0.96–
100.0). The 12-month correct use unintended preg-
nancy rate for the CMM group was 2.8%—i.e., a
survival rate of 0.972 (95% CI 0.948–0.966). The 12-
month total pregnancy rate for the EHFM group
was 12.3%—i.e., a 12-month survival rate of 87.7%
(95% CI 0.831–0.923). The 12-month total pregnancy
rate for the CMM only group was 22.8%, with a sur-
vival rate of 0.772 (95% CI 0.704–0.84 0).
Regular Cycle Unintended Pregnancy Rates
There was a total of 40 unintended pregnancies
Volume 54, Number 3/March 2009 167
DO NOT DUPLICATE
© Copyrighted Material
with the reduced data set of women with only reg-
ular cycles. There were 15 unintended pregnancies
with the EHFM aided FAM (only 4 due to correct
use) and 25 unintended pregnancies with the CMM
only method (11 as a result of correct use). The 12-
month correct use unintended pregnancy rate of the
EHFM aided method was 2.3% (0.977 survival rate,
95% CI 0.955–0.999), and the total unintended preg-
nancy rate was 12.0% (0.882 survival rate, 95% CI
0.822–0.942). In comparison, the 12-month correct
use pregnancy rate of the CMM was 3.0%, and the
typical use was 23.0%.
Differences in Unintended Pregnancy Rates
A Fisher exact test showed a significant difference
in the total unintended pregnancies between the 2
groups for both the total and the reduced groups of
FAM users (p <0.05). Therefore, the hypothesis that
there would be fewer unintended pregnancies with
the EHFM aided method as compared to the CMM
method was supported.
Discussion
This retrospective, cohort study provided evidence
that a FAM of family planning that utilizes 2 bio-
logic indicators of fertility as a double check for the
beginning and end of the estimated fertile phase (in
this case cervical mucus signs along with urinary
metabolite threshold levels of E3G and LH) is more
effective than a single biologic indicator method—
i.e., cervical mucus observations alone. In fact, the
unintended pregnancy rate for the single indicator
FAM was almost double that of the single indicator
method. These results are supported by a recent
study that investigated the efficacy of a double
check method (utilizing cervical mucus changes,
basal body temperature and calendar calculations
to estimate the fertile phase) and obtained efficacy
results that approach the efficacy of the hormonal
oral contraceptive among women with regular
menstrual cycle lengths.
6
Furthermore, 2 older, ran-
domized studies that compared a single CMM only
method with cervical mucus plus the use of basal
body temperature as a double check for the end of
the fertile phase also provided evidence that a sec-
ond biologic check for the fertile phase is more ef-
fective.
25-27
These 2 randomized studies, however,
had some methodologic flaws in that the drop-out
rate of participants were considerable for both
groups and uneven.
9
Finally, the efficacy of the
CMM only method found in this study is similar to
the total unintended pregnancy rate in an earlier ef-
ficacy study of the same CMM (i.e., 18% vs. 20.5% in
the current study).
28
One of the reasons that a double check FAM
might be more effective than a single cervical
mucus FAM is that the cervical mucus sign can
often be confusing. Two studies have indicated that
women were unable to detect a peak day of cervical
mucus in approximately 17% of menstrual cycles
and hence had no indication for the end of the fer-
tile phase.
29,30
Furthermore, the same researchers
discovered a relatively low interrater concurrence
of cervical mucus recordings between 2 master
teachers of the cervical mucus only method; i.e.,
they often were not able to agree (retrospectively)
as to what days were fertile days or not based on
cervical mucus. Finally, cervical mucus is known to
overestimate the actual fertile phase by approxi-
mately 200%. Several studies have shown that the
average amount of fertile days as estimated by self-
observed cervicovaginal mucus is 11–12 days.
11,21,29
Since this was a cohort comparison study and not
a randomized comparison, there could be con-
founding factors to explain the results other than
use of a double versus a single biologic marker to
estimate the fertile phase of the menstrual cycle.
One reason could be that the single indicator
method could have had more women with irregu-
lar menstrual cycles. However, the single method
study had 78% of the women with regular menstru-
al as cycles compared to 74% with the hormonal
monitor aided method. So, too, it could be that the
hormonal monitor aided method had significantly
older women—i.e., there is a decline in fertility after
the age of 35. There was a significantly older mean
age in the EHFM group as compared to the CMM
only method in the larger data set but not with the
data set with only regular menstrual cycles. Al-
though there was no difference in the number of
children, the slightly older age of the females and
the higher (but not statistically significant number
of children) could mean that the EHFM group had
more couples who had completed their families and
were more consistent with the use of their FAM.
A final plausible contributing factor in efficacy
could be the participation and motivation of the
male partner. There was no difference in the mar-
riage rate, and both methods involve teaching the
couple, not just the woman participant. Other pos-
sible confounding factors, such as education level,
socioeconomic level, race, religion or ethnicity,
could have contributed to the results. However,
there is no good evidence that any of these social
168 The Journal of Reproductive Medicine
®
DO NOT DUPLICATE
© Copyrighted Material
demographics contributed to higher unintended
pregnancy rates. Furthermore, there were no signif-
icant differences in these demographics between
the 2 groups. Both groups were taken from similar
ethnic and socioeconomic classes. Most (>80%) of
the participants were white, Catholic, had at least a
high school education and were in the middle to
upper socioeconomic class.
From a clinical practice standpoint, teaching cou-
ples a multiple biologic indicator FAM is more com-
plex than a single biologic indicator method. In ad-
dition, women at times will ignore one of the signs
of fertility when the signs do not agree. However,
the hormonal fertility monitor is very objective.
There is no guessing as to whether a given day has
low, high or peak fertility. Furthermore, there is ev-
idence that the LH surge is a more accurate indica-
tor of ovulation than cervical mucus.
14
At times the
monitor might provide a false positive LH reading
due to the variation in the LH surge. When this hap-
pens, the peak in the monitor and the cervical
mucus will not correlate. However, if women users
follow the rules of the method and wait until both
signs indicate infertility, there should be no
method-related pregnancies. To simplify the EHFM
aided FAM we have developed a simple fertility al-
gorithm as a double check for those women who do
not wish to use or have confusing cervical mucus
signs.
30
We conclude that an EHFM aided method of
FAM that utilizes a double check for the beginning
and end of the estimated fertile phase is more effec-
tive in helping couples to avoid pregnancy than a
CMM only FAM. However, we recommend verifi-
cation of these findings by a randomized, con-
trolled trial. Women and couples who wish to use
FAMs to achieve or avoid pregnancy should have
information as to the relative efficacy and ease of
use of these methods when making decisions as to
which method to use.
References
1. Leite IC, Gupta N: Assessing regional differences in contra-
ceptive discontinuation, failure and switching in Brazil. Re-
prod Health 2007;4:6
2. Moreau C, Cleland K, Trussell J: Contraceptive discontinua-
tion attributed to method dissatisfaction in the United States.
Contraception 2007;76:267–272
3. Moreau C, Trussell J, Rodriquez G, et al:: Contraceptive fail-
ure in France: Results from a population-based survey. Hum
Reprod 2007;22:2422–2427
4. Finer L, Henshaw S: Disparities in rates of unintended preg-
nancy in the United States, 1994 and 2001. Perspect Sex Re-
prod Health 2006;38:90–96
5. De Irala J, Lopez del Burgo C, Lopez de Fez C, et al: Women’s
attitudes towards mechanisms of action of family planning
methods: Survey in primary health centres in Pamplona,
Spain. BMC Womens Health 2007;7:1–10
6. Frank-Herrmann P, Heil J, Gnoth C, et al: The effectiveness
of a fertility awareness based method to avoid pregnancy in
relation to a couple’s sexual behavior during the fertile time:
A prospective longitudinal study. Hum Reprod 2007;22:
1310–1319
7. Severy LJ, Robinson J, Findley-Klein C, et al: Acceptability of
a home monitor used to aid in conception: Psychosocial fac-
tors and couple dynamics. Contraception 2006;73:65–71
8. Arevalo M, Jennings V, Sinai I: Efficacy of a new method of
family planning: The Standard Days Method. Contraception
2002;65:333–338
9. Grimes DA, Gallo MF, Grigorieva V, et al: Fertility aware-
ness-based methods for contraception: Systematic review of
randomized controlled trials. Contraception 2005;72:85–90
10. Trussell J: Contraceptive failure in the United States. Contra-
ception 2004;70:89–96
11. Arevalo M, Jennings V, Nikula M , et al: Efficacy of the new
TwoDay Method of family planning. Fertil Steril 2004;82:
885–892
12. Frank-Herrmann P, Gnoth C, Baure S, et al: Determination of
the fertile window: Reproductive competence of women:
European cycle databases. Gynecol Endocrinol 2005;20:
305–312
13. Bonnar J, Flynn A, Freundl G, et al: Personal hormone mon-
itoring for contraception. Br J Fam Plann 1999;24:128–134
14. Guida M, Tommaselli GA, Palomba S, et al: Efficacy of meth-
ods for determining ovulation in a natural family planning
program. Fertil Steril 1999;5:900–904
15. Behre HM, Kuhlage J, Gassner C, et al: Prediction of ovula-
tion by urinary hormone measurements with the home use
ClearPlan Fertility Monitor: Comparison with transvaginal
ultrasound scans and serum hormone measurements. Hum
Reprod 2000;13:2478–2482
16. Tanabe K, Susumu N, Jand K, et al: Prediction of the poten-
tially fertile period by urinary hormone measurements using
a new home-use monitor: Comparison with laboratory hor-
mone analyses. Hum Reprod 2001;16:1619–1624
17. Ecochard R, Boehringer H, Rabilloud M, et al: Chronological
aspects of ultrasonic, hormonal, and other indirect indices of
ovulation. Br J Obstet Gynaecol 2001;108:822–829
18. May K: Home monitoring with the ClearPlan Easy Fertility
Monitor for fertility awareness. J Int Med Res (suppl 1) 2001;
29:14A–20A
19. Robinson JE, Waklin M, Elllis JE: Increased pregnancy rate
with use of the Clearblue Easy Fertility Monitor. Fertil Steril
2007;87:329–334
20. Fehring RJ, Schneider M, Raviele K, et al: Efficacy of cervical
mucus observations plus electronic hormonal fertility moni-
toring as a method of natural family planning. J Obstet Gy-
necol Neonatal Nurs 2007;36:152–160
21. Fehring RJ, Schneider M, Barron ML: Efficacy of the Mar-
quette method of natural family planning. MCN Am J
Volume 54, Number 3/March 2009 169
DO NOT DUPLICATE
© Copyrighted Material
Matern Child Nurs (in press)
22. Fehring RJ: Usefulness of electronic hormonal fertility mon-
itoring for avoiding pregnancy. In Human Fertility: Where
Faith and Science Meet. Edited by R Fehring, T Notare. Mil-
waukee, Marquette Press, 2007, pp 125–140
23. Fehring R: Accuracy of the peak day of cervical mucus as a
biological marker of fertility. Contraception 2002,66:231–235
24. Fehring R, Lawrence D, Philpot C: Use-effectiveness of the
Creighton model ovulation method of natural family plan-
ning. J Obstet Gynecol Neonatal Nurs 1994;23:303–309
25. Medina JE, Cifuentes A, Abernathy JR, et al: Comparative
evaluation of two methods of natural family planning in Co-
lumbia. Am J Obstet Gynecol 1980;138:1142–1147
26. Wade ME, McCarthy P, Abernathy JR, et al: Randomized
prospective study of the use-effectiveness of two methods of
natural family planning: An interim report. Am J Obstet Gy-
necol 1979;134:628–631
27. Wade ME, McCarthy P, Braunstein GD, et al: A randomized
prospective study of the use-effectiveness of two methods of
natural family planning. Am J Obstet Gynecol 1981;141:368–
376
28. Howard MP, Stanford JB: Pregnancy probabilities during
use of the Creighton Model Fertility Care System. Arch Fam
Med 1999;8:391–402
29. Fehring RJ, Raviele K, Schneider M: A comparison of the fer-
tile phase as determined by the Clearplan Easy Fertility
Monitor and self-assessment of cervical mucus. Contracep-
tion 2004;69:9–14
30. Fehring R: New low and high tech calendar methods of fam-
ily planning. J Midwif Womens Health 2005;50:31–37
170 The Journal of Reproductive Medicine
®
DO NOT DUPLICATE
© Copyrighted Material
... The FIE with daily serum/fingerstick E2 levels-or possibly daily urinary E3G levels-is not envisioned as a stand-alone technology for FAM technology. The urine LH and urine P3G tests are already available to consumers and strong indicators of ovulation and the luteal phase [1][2][3][21][22][23]. Subjective observations of cervical-vaginal fluid and possible future mucin (CA125) levels in cervical-vaginal fluid could serve in combination as fertile signals [4,21,22]. ...
... The urine LH and urine P3G tests are already available to consumers and strong indicators of ovulation and the luteal phase [1][2][3][21][22][23]. Subjective observations of cervical-vaginal fluid and possible future mucin (CA125) levels in cervical-vaginal fluid could serve in combination as fertile signals [4,21,22]. The FIE would be employed in the preovulatory phase and could be particularly useful in cycles where there is a prolonged phase of follicular development to ovulation. However as shown, the FIE signature can also strikingly signal the transition to luteal phase with a high +FIE (on Day −1) to indFIE (on Day 0) to low −FIE (on Day +1). ...
Article
Full-text available
Background and Objectives: Urinary hormone home monitoring assays are now available for fertility awareness methods (FAMs) of family planning, but lack sensitivity and precision in establishing the start of the fertile phase. We hypothesized that with a suitable algorithm, daily serum or blood estradiol (E2) levels could serve as a better analyte to determine the phase of the ovulatory cycle and the fertile start day (FSD). Materials and Methods: Published day-specific serum E2 levels, indexed to the serum luteinizing hormone (LH) peak, were analyzed from three independent laboratories for a threshold for a FSD. A fertility indicator quation (FIE) was discovered and tested with these data and a FSD was determined using the mean or median and variance ranges of the day-specific E2 data. Results: The considerable variance of day-specific serum E2 levels made an absolute serum E2 indicator for phase of cycle problematic. However, a FIE was discovered which maps the day-specific E2 levels of the ovulatory cycle enabling the fertile phase and transition to the luteal phase to be signaled. In this equation, FIE(D) is the value of FIE on day, D, of the cycle and has both a magnitude and sign. The magnitude of FIE(D) is the product of the normalized change in day-specific E2 levels over two consecutive intervals, (D-2, D-1) and (D-1, D), multiplied by 100, and is formulated as: (E2 (on D-1) − E2 (on D-2))/E2 (on D-2) × (E2(on D) − E2 (on D-1))/E2 (on D-1) × 100. The sign of FIE(D) is either + or − or ind (indeterminate) and is assigned on the basis of the direction of this product. Using a FIE threshold of ≥2.5 as the start of the fertile phase, the FSDs were Day −5 or Day −6, with FSD Day −4 for an outlier set of E2 levels. The maximum FIE value ranged 9.5-27.8 and occurred most often on Day −2. An inflection point with a large change in FIE magnitude and change in sign from + to − always occurred at Day 0 for all sets of day-specific E2 data signaling transition to the luteal phase. Conclusions: The fertility indicator equation, a product of two sequential normalized changes in serum E2 levels with a sign indicating confidence in direction of change, is powerful in identifying the fertile phase and subsequent transition to the postovulatory phase and may serve as a useful algorithm for FAMs of family planning.
... 12 There is interest in the development of objective metrics, mainly urinary hormonal levels, to identify time of cycle for fertility awareness and natural family planning. [13][14][15] The Persona monitor (Swiss Precision Diagnostics GmbH, Switzerland) is marketed for contraception in Europe, and the Clearblue Easy monitor (Swiss Precision Diagnostics) is marketed for assistance in achieving pregnancy in North America and Europe; the algorithms incorporated into the software for these apparatuses are based upon measurements of urinary estrone-3glucuronide and LH and knowledge of the potential period of fertility. 15 Conception occurs only when sexual intercourse takes places during a 6-day in-terval that ends on the day of ovulation. ...
... 24 The data were grouped around these intervals since the interval [−4, +1] is expected to be the period of potential fertility. [13][14][15][16][17] Using this linear mixed-effects model, Qvaginal CA125 levels during this period of potential fertility were estimated to be higher than the preovulatory and postovulatory intervals, [start, −5] and [+2, end], respectively, with a p value <0.02. ...
Article
OBJECTIVE: To develop an assay for vaginal CA125 and determine if vaginal levels correlate with the phase of the menstrual cycle. STUDY DESIGN: Fifteen women through a total of 20 ovulatory cycles obtained daily vaginal swabs for assay. Sampling began within the first 3 days after menses and continued into the luteal phase. The subjects eluted the cotton swab tips in vials contaming a standard volume of water. At the completion of each cycle the vial concentrations of CA125 were measured with the Siemens IMMULITE 2000. These "Qvaginal" levels of CA125 were indexed to the first day of positive urine luteinizing hormone signal, day 0. RESULTS: Qvaginal CA125 levels ranged from background (<1 U/mL) to 5,740 U/mL and followed a periodic pattern: low during the early preovulatory phase, a maximum generally during day -4 to day +1, and low during the luteal phase. Qvaginal CA125 levels during the interval of presumptive fertility, day -4 to day +1, were statistically higher than levels during the preovulatory interval ending at day -5 and the postovulatory interval starting at day +2 (p value <0.02). CONCLUSIONS: The vaginal swab assay for CA125 can potentially track the phase of the ovulatory cycle and therefore may have applications for fertility awareness and diagnosis of reproductive disorders:
... It has been shown that this correlates well with gold-standard serum LH levels and serial ultrasound scans to ascertain ovulation status Barron 2008, Roos et al. 2015). There appears to some superiority of the combined symptom and hormonal (symptohormonal) observations in the Marquette Method over mucus-only methods (Fehring et al. 2009, Fehring, Schneider, and Bouchard 2017, Fehring et al. 2007, Fehring, Schneider, Raviele, et al. 2013). ...
Chapter
Full-text available
Alzheimer`s disease (AD) is the most common and incurable form of dementia. The present AD treatments produce only an uncertain amelioration of symptoms. Research on AD has particularly focused on the central nervous system. Though, some systemic and peripheral abnormalities are now clearly understood that are associated to AD. Current research on these alterations that leads to AD are becoming further defined more evidently. Two microscopic features contribute for the depiction of the disease, the amyloid plaques and neurofibrillary tangles. All these aspects are accountable for the deliberate and gradual weakening of memory that disturb the cognitive control, language, thinking and personality. For the diagnosis of AD, some neuropsychological tests are being performed in various spheres of cognitive functions. To date, cholinesterase inhibitors are used as a drug for the treatment of AD, because these are the individual drugs that have depicted substantial enhancements in the cognitive functions of AD patients. Despite the efficacy of cholinesterase inhibitors, the degeneration of neurons is continuing even while being treated an AD patient. For this cause, further biochemical pathways related to pathophysiology of AD have been revealed as an alternative for the treatment of these conditions such as hindrance of glycogen synthase kinase-3β and β-secretase. The present chapter aims to conduct a review of the pathophysiology, symptoms, epidemiology, analysis and treatment of AD.
... Fertility awareness · Contraception · Symptothermal method of family planning · Menstrual cycle · Desire to have children östrogene Aktivität bei Oligo- und Amenorrhö F Ovulations- und Lutealphasendiagnostik können gezielt terminiert werden [15] Im Hinblick auf Zykluscomputer und Softwareprogramme, die heute zunehmend in der Familienplanung eingesetzt werden, verweisen wir auf unsere Publikationen [5,10,11]. ...
Article
Full-text available
Due to new and further developments, the field of natural family planning methods has become confusing. The conventional nomenclature-the temperature method, the Billings method, the symptothermal method-includes numerous variations of natural methods that vary substantially in efficacy, practicability, and acceptability. The new name of the evidence-based symptothermal method of the German working group NFP (Natural Family Planning) is sensiplan® (www.sensiplan.eu), which has a proven high efficacy rate. Women can reliably and independently determine the fertile window of their individual cycle without much effort. Thus, this method can be used for family planning and differentiated monitoring of a woman's cycle.
Article
Background A new fertility monitor is now available that provides quantitative measurement of urinary hormones, but clinical use requires validation against an established fertility monitor that provides only qualitative results. Research design and methods Two fertility monitors were compared using daily first morning urine samples over 3 cycles of use in 21 women users with experience using a fertility monitor with the Marquette Method of Natural Family Planning. Results Women were aged 33.4 ± 5.5 years and had menstrual cycles ranging between 23-41 days. The quantitative Mira Monitor estimates of ovulation were highly correlated with the qualitative ClearBlue Fertility Monitor (CBFM) estimates of ovulation. Both monitors provided an accurate estimate of the fertile window. Conclusions In this preliminary trial, the Mira monitor was shown to be effective at delineating the fertile window and ovulation. We demonstrated the feasibility of applying the Marquette Method algorithm with the use of the Mira monitor. Satisfaction differences between the two monitors did not reach statistical significance. We anticipate that quantitative fertility monitoring will give couples and health care providers new and unprecedented insights into the menstrual cycle and fertility.
Article
A review of 23 research articles to examine fertility awareness-based methods revealed biologic indicators and tracking methods to identify the fertile window in reproductive-aged women. This literature review indicated that a woman's cycle regularity is a major determinant of which method is best. Additionally, the woman's desire to achieve a pregnancy and her preference regarding the intensity of training are factors in method choice. Some evidence suggests that use of at least two biologic indicators is most effective for determining the fertility window. Recommended web and mobile applications also are discussed.
Article
Objective: To summarize best available prospective data on typical and perfect use effectiveness of fertility awareness-based methods for avoiding pregnancy. Data sources: We conducted a systematic review of studies published in English, Spanish, French, or German by June 2017 in MEDLINE, EMBASE, CINAHL, Web of Science, and ClinicalTrials.gov. Methods of study selection: We reviewed 8,755 unique citations and included 53 studies that contained 50 or greater women using a specific fertility awareness-based method to avoid pregnancy, calculated life table pregnancy probabilities or Pearl rates, and prospectively measured pregnancy intentions and outcomes. We systematically evaluated study quality. Tabulation, integration, and results: Of 53 included studies, we ranked 0 high quality, 21 moderate quality, and 32 low quality for our question of interest. Among moderate-quality studies, first-year typical use pregnancy rates or probabilities per 100 woman-years varied widely: 11.2-14.1 for the Standard Days Method, 13.7 for the TwoDay Method, 10.5-33.6 for the Billings Ovulation Method, 4-18.5 for the Marquette Mucus-only Method, 9.0-9.8 for basal body temperature methods, 13.2 for single-check symptothermal methods, 11.2-33.0 for Thyma double-check symptothermal methods, 1.8 for Sensiplan, 25.6 for Persona, 2-6.8 for the Marquette Monitor-only Method, and 6-7 for the Marquette Monitor and Mucus Method. First-year perfect use pregnancy rates or probabilities among moderate-quality studies were 4.8 for the Standard Days Method, 3.5 for the TwoDay Method, 1.1-3.4 for the Billings Ovulation Method, 2.7 for the Marquette Mucus Method, 0.4 for Sensiplan, 12.1 for Persona, and 0 for the Marquette Monitor. Conclusion: Studies on the effectiveness of each fertility awareness-based method are few and of low to moderate quality. Pregnancy rates or probabilities varied widely across different fertility awareness-based methods (and in some cases, within method types), even after excluding low-quality studies. Variability across populations studied precludes comparisons across methods.
Article
Purpose: The aims of this study were to determine and compare extended use-effectiveness of an online nurse-managed fertility education service program among women (and subgroups of women) seeking to avoid pregnancy. Study design and methods: This was a 24-month prospective study of a university-based online Web site with 663 nonbreastfeeding women using an online charting system to avoid pregnancy. Participants tracked their fertility online with either cervical mucus monitoring, electronic hormonal fertility monitoring, or both fertility indicators. Unintended pregnancies were validated by professional nurses. Results: Participants had a mean age of 30.4 years (SD = 6.3) and mean 1.7 children (SD = 2.0). Among the 663 nonbreastfeeding participants there were 2 unintended pregnancies per 100 at 24 cycles of correct use and 15 pregnancies at 24 cycles of typical use. However, the 212 women using the electronic fertility monitor had a typical use unintended pregnancy rate of 6 at 24 cycles of use in comparison with the 118 women using cervical mucus monitoring that had a typical use pregnancy rate of 19 at 24 cycles and with the 333 women using both fertility indicators that had a pregnancy rate of 18 at 24 cycles of use. Clinical implications: Use of the fertility monitor to estimate fertility among nonbreastfeeding women provides the most secure method of avoiding pregnancy.
Article
IntroductionThe length of periodic abstinence, due to overestimation of the fertile phase of the menstrual cycle, is often a cause for dissatisfaction, discontinuation, and user error with natural family planning (NFP) methods. The objective of this research was to compare the length of required abstinence (ie, estimated fertility) and coital frequency between 2 NFP methods. Methods This was an analysis of data from a 12-month prospective comparison study in which participants were randomized into either an electronic hormonal fertility monitor (EHFM) group or a cervical mucus monitoring (CMM) groupboth of which included a fertility algorithm as a double check for the beginning and end of the estimated fertile window. The number of days of estimated fertility and coitus was extracted from each menstrual cycle of data, and t tests were used to compare the means of these 2 variables between the 2 NFP methods. ResultsThe study involved 197 women (mean [SD] age 29.7 [5.4]) who used the EHFM to estimate the fertile window and 160 women (mean [SD] age 30.4 [5.3]) who used CMM to estimate the fertile window. They produced 1,669 menstrual cycles of data. After 12 months of use, the EHFM group had statistically fewer days of estimated fertility than the CMM group (mean [SD] days, 13.25 [2.79] vs 13.68 [2.99], respectively; t = 2.07; P = .039) and significantly more coitus (mean [SD] coital acts, 4.22 [3.16] vs 4.05 [2.88], respectively; t = 1.17; P = .026). DiscussionThe use of the EHFM seems to provide more objectivity and confidence in self-estimating the fertile window and using nonfertile days for intercourse when avoiding pregnancy. (C) 2014 by the American College of Nurse-Midwives.
Article
The “Current Medical Research” feature focuses on issues relevant to natural family planning and the beginning of life.
Article
The Standard Days Method is a fertility awareness-based method of family planning in which users avoid unprotected intercourse during cycle Days 8 through 19. A prospective multi-center efficacy trial was conducted to test, in a heterogeneous population, the contraceptive efficacy of the Standard Days Method. A total of 478 women, age 18–39 years, in Bolivia, Peru, and the Philippines, with self-reported cycles of 26–32 days, desiring to delay pregnancy at least one year were admitted to the study. A single decrement multi-censoring life table analysis of the data indicate a cumulative probability of pregnancy of 4.75% over 13 cycles of correct use of the method, and a 11.96% probability of pregnancy under typical use. This article describes the study and the results. Results suggest that despite its requirement that couples modify their sexual behavior when the woman is fertile, the Standard Days Method provides significant protection from unplanned pregnancy and is acceptable to couples in a wide range of settings.
Objective: To determine the use effectiveness of the Creighton model ovulation method in avoiding and achieving pregnancy. Design: Prospective, descriptive. Setting: A natural family planning clinic at a university nursing center. Participants: Records and charts from 242 couples who were taught the Creighton model. The sample represented 1,793 months of use of the model. Main outcome measure: Creighton model demographic forms and logbook. Results: At 12 months of use, the Creighton model was 98.8% method effective and 98.0% use effective in avoiding pregnancy. It was 24.4% use effective in achieving pregnancy. The continuation rate for the sample at 12 months of use was 78.0%. Conclusion: The Creighton model is an effective method of family planning when used to avoid or achieve pregnancy. However, its effectiveness depends on its being taught by qualified teachers. The effectiveness rate of the Creighton model is based on the assumption that if couples knowingly use the female partner's days of fertility for genital intercourse, they are using the method to achieve pregnancy.
Article
This review provides an update of previous estimates of first-year probabilities of contraceptive failure for all methods of contraception available in the United States. Estimates are provided of probabilities of failure during typical use (which includes both incorrect and inconsistent use) and during perfect use (correct and consistent use). The difference between these two probabilities reveals the consequences of imperfect use; it depends both on how unforgiving of imperfect use a method is and on how hard it is to use that method perfectly. These revisions reflect new research on contraceptive failure both during perfect use and during typical use.
Article
To determine the effectiveness of the Marquette Method (MM) of natural family planning (NFP) as a method of avoiding pregnancy. This was a 12-month retrospective evaluation of the MM system of NFP. Two hundred and four women (mean age, 28.6 years) and their male partners (mean age, 30.3 years) who sought to learn a method for avoiding pregnancy with the MM from four clinical sites were taught to track their fertility by self-observation of cervical mucus, by use of an electronic monitor that measures urinary levels of estrone-3-glucuronide and luteinizing hormone, and by use of basal body temperature. All unintended pregnancies were evaluated by professional nurses as to whether they were intended or not. Pregnancy rates over 12 months of use were determined by survival analysis. There were a total of 12 unintended pregnancies, only 1 with correct use. The 12-month "correct use" pregnancy rate was 0.6 (i.e., 99.4% effective) and the "typical use" (total pregnancy rate) was 10.6 (i.e., 89.4% effective) per 100 users. When used correctly, the MM system of NFP is an effective means of avoiding pregnancy. The efficacy of the MM system includes proper preparation of the professional nurse NFP teachers.
Article
Data accumulated to date from the Los Angeles study indicate that the total termination rate for 12 months from the beginning of the training period and from formal entry into the study was high for the ovulation method (OM), and symptothermal method (STM). Voluntary withdrawal was the highest single reason for termination in both methods. The 12 month voluntary withdrawal rate, measured from formal entry into the study, was significantly higher for OM users. Pregnancy rates measured from both the beginning of training and formal entry into the study were significantly higher for OM users than for STM users. Complete analysis of the data collected during the study is currently in progress. It is anticipated that some of the causes for the differences in pregnancy rates and withdrawal rates between the two methods can be identified.
Article
The final results of a prospective comparative study of two methods of natural family planning indicate a significant difference in the 12 month net cumulative pregnancy rates between the ovulation and symptothermal methods. These differences are on the order of two to one in favor of the symptothermal method. Pearl pregnancy rates confirm similar differentials between the two methods. Dropout rates for both methods were high. Lack of interest or dissatisfaction with the method was the major reason for dropout training while pregnancy or desire for pregnancy were the major reasons for dropout during the formal phase of the study.
Article
Results of a comparative study of the ovulation method (OM) and symptothermal method (STM) of natural family planning in Colombia are presented. Recruitment of volunteer couples began in August, 1976, and continued through December, 1978, during which time 566 couples were randomly assigned to one or the other of the two methods. The study included 3 to 5 months of training in the method assigned, after which the couples entered the follow-up phase of the study. They remained in follow-up until (1) they dropped out or (2) the study closed in June, 1979. Total dropout rates were high for both methods of natural family planning. One year after entry into the follow-up phase of the study, net pregnancy rates were 24.2% for OM users and 19.8% for STM users. Gross pregnancy rates were 29.2% for OM and 26.1% for STM. Differences in pregnancy rates between the two methods were not statistically significant.
Article
To determine the effectiveness and acceptability of personal hormone monitoring for contraception. A large prospective study was carried out on personal hormone monitoring for contraception when used with abstinence during the identified fertile days. Three country study under the auspices of the departments of Obstetrics and Gynaecology of the Universities of Birmingham, Dublin and Dusseldorf Seven hundred and ten women, median age 30, were recruited from the general population. They were required to have regular menstrual cycles (23-35 days) and to be delaying their next pregnancy. Personal hormone monitoring consists of a hand held monitor and disposable test sticks which measure changes in urinary concentrations of oestrone-3-glucuronide and luteinising hormone. An algorithm estimated the fertile days which were displayed by a red light. One hundred and sixty two pregnancies occurred in 7209 cycles of use, of which 67 were method related pregnancies. The 13 cycle life-table method pregnancy rate (95 per cent CI) was 12. 1 per cent (9.3-14.8). The system allowed analysis of the effect of changes to the algorithm to modify the defined fertile period. As a result the algorithm was changed to increase the median warning of the luteinising hormone surge to six days. With the revised algorithm, half of the method pregnancies would have been prevented giving a calculated method pregnancy rate of 6.2 per cent (4.2-8.3) and method efficacy of 93.8 per cent. The continuation rate after 13 cycles was 78 per cent. Personal hormone monitoring proved simple to use and will be of value to women who do not want to use other methods of contraception.