Luteal phase support with progesterone in intrauterine insemination: a prospective randomized study.
ABSTRACT Abstract Objective: To determine the effect of vaginal progesterone as luteal support on pregnancy outcomes in infertile patients who undergo ovulation induction with gonadotropins and intrauterine insemination (IUI). Design: Prospective randomized trial. Setting: Tertiary referral center. Patient(s): About 398 patients with primary infertility were treated during 893 ovarian stimulation and IUI cycles from February 2010 to September 2012. Methods: All patients underwent ovarian stimulation with gonadotropins combined with IUI. Patients in the supported group received vaginal micronized progesterone capsules 200 mg once daily from the day after insemination until next menstruation or continuing for up to 8 weeks of pregnancy. Women allocated in the control group did not receive luteal phase support. Main outcome measure(s): Livebirth rate, clinical pregnancy rate and early miscarriage rate per cycle. Result(s): Of the 893 cycles, a total of 111 clinical pregnancies occurred. There were no significant differences between supported with progesterone and unsupported cycle in terms of livebirth rate (10.2% versus 8.3%, respectively, with a p value = 0.874) and clinical pregnancy rate (13.8% compared with 11.0% in unsupported cycle with a p value = 0.248). An early miscarriage rate of 3.6% was observed in the supported cycles and 2.7% in the unsupported cycles, with no significant differences between the groups (p value = 0.874). Conclusion(s): In infertile patients treated with mildly ovarian stimulation with recombinant gonadotropins and IUI, luteal phase support with vaginal progesterone is not associated with higher livebirth rate or clinical pregnancy rate compared with patients who did not receive any luteal phase support.
- [Show abstract] [Hide abstract]
ABSTRACT: World-wide, intrauterine insemination (IUI) is still one of the most applied techniques to enhance the probability of conception in couples with longstanding subfertility. The outcome of this treatment option depends on many confounding factors. One of the confounding factors receiving little attention is the quality of the luteal phase. From IVF studies, it is known that ovarian stimulation causes luteal phase deficiency. Based on the best available evidence, this short review summarizes the indications for mild ovarian stimulation combined with IUI and the optimal stimulation programme. While it has been established that stimulated IVF/intracytoplasmic sperm injection cycles have deficient luteal phases, the question remains whether the quality of the luteal phase when only two or three corpora lutea are present (as is the case in stimulated IUI cycles) is impaired as well. There are too few large non-IVF trials studying luteal phase quality to answer this question. Recently a randomized trial has been published that investigated luteal phase support in an IUI programme. This study is discussed in detail. It is recommended to apply luteal phase support in stimulated IUI cycles only when proven costeffective. Further trials are mandatory to investigate both endometrial and hormonal profile changes in the luteal phase after mild ovarian stimulation, and the cost-effectiveness of luteal support in IUI programmes.Reproductive biomedicine online 01/2009; 19 Suppl 4:4239. · 2.68 Impact Factor
- [Show abstract] [Hide abstract]
ABSTRACT: To evaluate the effects of three different luteal phase support protocols on pregnancy and implantation rates, as well as luteal phase hormone profile in intracytoplasmic sperm injection-ET cycles. A prospective, randomized study. A tertiary teaching and research hospital. Two hundred eighty-eight patients who were undergoing intracytoplasmic sperm injection with a long protocol of controlled ovarian hyperstimulation. Group 1 (E(2) + P) received daily P plus 4 mg of E(2), group 2 (hCG + P) received P plus 1,500 IU of hCG, and group 3 (P only) received daily vaginal P gel. Blood samples were drawn on the day of hCG administration, as well as 7 and 10 days after the hCG for the E(2) and P measurements. The clinical pregnancy rate. No difference existed between the E(2) + P and hCG + P groups with respect to pregnancy rate, but it was significantly lower in the P-only group.The implantation rate was significantly lower in the P-only group than in the other groups.The highest miscarriage rate was in the P-only group (38%). In assisted reproductive technology cycles including treatment with GnRH agonist, adding 4 mg of oral E(2) to P during the luteal phase significantly increased the pregnancy and implantation rates and decreased the miscarriage rate compared with the use of P only.Fertility and sterility 03/2011; 95(3):985-9. · 3.97 Impact Factor
- [Show abstract] [Hide abstract]
ABSTRACT: Limited data exist concerning the need for luteal support in clomiphene citrate-stimulated intrauterine insemination (IUI) cycles. The addition of progesterone became an established clinical practice, despite the absence of evidence of effectiveness. A prospective randomized controlled trial was performed in a tertiary referral centre to assess the effect of intravaginal micronized progesterone as luteal support on the probability of ongoing pregnancy in patients stimulated with clomiphene citrate for IUI. Normo-ovulatory women, ≤ 36 years of age, undergoing ovarian stimulation with clomiphene citrate (50 mg) for IUI (n = 468) were randomized during the period from September 2008 to December 2009. Patients were randomized, either to receive luteal phase support (n = 243) in the form of vaginal micronized progesterone in three separate doses (200 mg, 3 times a day), or to the control group who did not receive luteal phase support (n = 225). Data from 400 women were analysed. Following the first interim analysis, the study was prematurely cancelled as an extremely low total pregnancy rate was found. No difference was observed in ongoing pregnancy between patients who did, or did not, receive vaginal progesterone as luteal support [8.7% (17/196) versus 9.3% (19/204), respectively, P = 0.82; difference -0.6%, 95% confidence interval (CI): -6.4, 5.2]. Additionally, the early pregnancy loss rate did not differ between groups (1.5% progesterone group versus 2% no progesterone group, P = 0.78; difference -0.5%, 95% CI: -3.6, 2.7). Routine supplementation of the luteal phase with vaginal progesterone does not seem to improve pregnancy rates in normo-ovulatory women stimulated with clomiphene citrate for IUI. Clinical trials.gov:NCT01046708.Human Reproduction 10/2010; 25(10):2501-6. · 4.67 Impact Factor