Evaluate the Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination
The proposal of This study approved by our institutional review boards and institution's
ethical committee, and all Participants will sign a written consent before enter to study.
All patients will be randomly divided into two groups, A and B. Stimulation will begin on
day 3 with the administration of 100 mg of clomifen citrate(CC) daily for 5 days. On day 8,
ethinyl estradiol will be given daily for 5 days in group A and placebo will be given for 5
days in group B. Plasma levels of estradiol(E2), Luteinizing hormone (LH) and
Follicle-stimulating hormone (FSH) will be evaluated on days 3 and 13 of the menstrual
cycle. Ultrasound examination will be done on days 3, 13 and days of HCG administration and
IUI for determining of endometrial thickness, number of follicles and size of the dominant
follicle.
When the diameter of at least one follicle reached equal or greater than 18 mm, human
chronic gonadotrophin (HCG) 10,000 IU will be administered.
The pulsatility index also will be recorded in both uterine arteries on day of HCG
administration. A single IUI will be performed 24-36 hours after the administration of hCG.
Pregnancy will be confirmed by increasing level of concentration of serum βHCG which will
be assessed 14 days after IUI
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Clinical Pregnancy rate
Usage of clomifen citrate on special days can increase pregnancy rate
4-6 weeks after embryos transfer(ET)
Yes
hamid gourabi, PhD
Study Chair
President of Royan Institute
Iran: Ethics Committee
Royan-Emb-010
NCT01219101
September 2009
April 2011
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