The Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination

NCT01219101 ↗

Phase 4 Completed 95 enrolled Royan Institute

RandomizedParallel-groupQuadruple-blindTreatment

Summary

According to the studies CC is successful at inducing ovulation in 50%-75% of cases, but only 30-40% becomes pregnant. The difference has been attributed to a negative action of clomifen citrate(CC) in the form of prolonged antiestrogenic effects on endometrial receptivity. For avoiding of these negative effects, giving ethinyl estradiol in sufficient dosages may be effective. The purpose of this study is comparing pregnancy rates after IUI in women who use CC alone and those who use CC in combination with ethinyl estradiol

Timeline

Start: 2011-03
Primary completion: 2012-11
Completion: 2013-02

Outcome

Met primary endpoint

paper clinical pregnancy was higher among participants who received CC and EE (13 [29%]) than among those in the control group (5 [10%]; P =0 .02). PMID 26391671 ↗

Publications

Moini A, Ahmadi F, Jahangiri N, Ahmadi J, Akhoond MR. A randomized controlled trial evaluating the effect of ethinyl estradiol during clomiphene citrate cycles among women with polycystic ovary syndrome. Int J Gynaecol Obstet. 2015 Nov;131(2):129-32. doi: 10.1016/j.ijgo.2015.06.032. Epub 2015 Sep 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ethinyl estradiol	Small molecule	0.05 mg	—
Background	Clomiphene Citrate	Other / unclassified	100 mg	—