Clinical Trial: Concomitant CC and E2 Versus CC Alone in Ovulation Induction

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Concomitant Clomiphene Citrate and Estradiol Versus Clomiphene Citrate Alone in Ovulation Induction: a Randomized Controlled Trial

Brief Summary: The purpose of this study is to evaluate the effect of concomitant administration of estradiol during use of clomiphene citrate (CC) for induction of ovulation in infertile women.

Detailed Summary: Women will be randomly divided into two groups; CC-E2 group and CC group. Women in the CC-E2 group will receive CC (100 mg/day for 5 consecutive days from day 2 of cycle) and estradiol (2 mg/day for 5 consecutive days from day 2 of cycle). Women in the CC group will receive CC (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo mimic estradiol (for 5 consecutive days from day 2 of cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of human chorionic gonadotropin (HCG) and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the midluteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle.
Sponsor: Maher elesawi kamel elesawi

Current Primary Outcome: Clinical pregnancy rate [ Time Frame: 6-8 weeks gestational age ]

Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women


Original Primary Outcome: number of follicles more than 18 mm [ Time Frame: after 14 days from start of clomiphene ]

Current Secondary Outcome: Endometrial thickness on day of HCG administration [ Time Frame: 3 months ]

Endometrial thickness by TVS on day of HCG administration


Original Secondary Outcome: endometrial thickness [ Time Frame: day14, 21 from start of clomiphene for endometrial thickness ]

Information By: Mansoura University

Dates:
Date Received: June 28, 2014
Date Started: June 2014
Date Completion: August 2018
Last Updated: March 21, 2017
Last Verified: March 2017