progestin primed ovarian stimulation protocol in the polycystic ovarian syndrome

Phase 2

Conditions: Female infertility, unspecified.
Female infertility, unspecified
N97.9

Registration Number: IRCT20110509006420N18

Lead Sponsor: Yazd University of Medical Sciences

Brief Summary: AbstractBackground: In vitro fertilization is an important therapy for women with the polycystic ovarian syndrome (PCOS). The use of new ways of improving clinical results is yet required. Objective: This study was aimed to investigate the efficacy of progesterone primed ovarian stimulation (PPOS) and compare with conventional antagonist protocol in PCOS.Materials and Methods:A total of 120 PCOS women who were candidates for assisted reproductive technology treatment were enrolled in this RCT and were placed into two groups, randomly (n = 60/each). The PPOS group received 20 mg/day Dydrogesterone orally since the second day of the cycle and the control group received antagonist protocol. The pregnancy outcomes including the chemical and clinical pregnancy, the miscarriage rate, and the percent of gestational sacs/transferred embryos were compared in two groups.Results:Number of MII oocyte, maturity rate, Number of 2 pronuclei (2PN) and serum estradiol levels on trigger day were statistically lower in PPOS group (p = 0.019, p =0.035, p = 0.032, p = 0.030), respectively. Serum LH level on trigger day in PPOSgroup was higher than antagonist group (p = 0.005). Although there wasn’t severe ovarian hyperstimulation syndrome in any participants, mild and moderate ovarian hyperstimulation syndrome was less in PPOS group (p = 0.001). Also, the chemical and clinical pregnancy rates were higher in the antagonist group, although it was not statistically significant (p = 0.136, p = 0.093 respectively).Conclusion: Our study demonstrates that PPOS does not improve the chemical and clinical pregnancy rate of infertile women with PCOS.

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 100

Inclusion Criteria

infertile PCOS patients which are candidate for ART

Exclusion Criteria

women older than 40 years old
History of endocrine disorder
Severe endometriosis
Azoospermia

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chemical pregnancy. Timepoint: Two weeks after embryo transfer. Method of measurement: Serum BhCG.;Clinical pregnancy. Timepoint: Two weeks after positive BhCG. Method of measurement: sonography.

Secondary Outcome Measures

Name	Time	Method
Miscarriage rate. Timepoint: Loss of pregnancy before 20 gestational week. Method of measurement: Absence of fetal heart activity in ultra sound sonography.