Concomitant CC and E2 Versus CC Alone in Ovulation Induction

Phase 4

• Conditions: Infertility; Anovulation
• Interventions: Drug: Clomiphene citrate and Placebo; Drug: Clomiphene citrate and Estradiol

• Registration Number: NCT02186782
• Lead Sponsor: Maher elesawi kamel elesawi

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 Description

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-28
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22
• Primary Completion: 2018-07
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• Infertile women with eugonadotrophic anovulation/oligoovulation.
• Unexplained infertility.

Exclusion Criteria

• Age < 20 or > 35 years.
• Body mass index (BMI) < 18.5 kg/m2 or > 25 kg/m2.
• Presence of any infertility factor other than anovulation/oligoovulation.
• Previous history of ovarian surgery or surgical removal of one ovary.
• Previous exposure to cytotoxic drugs or pelvic irradiation.
• Metabolic or hormonal abnormalities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clomiphene citrate group	Clomiphene citrate and Placebo	Women will receive clomiphene citrate and placebo
Clomiphene citrate-Estradiol group	Clomiphene citrate and Estradiol	Women will receive clomiphene citrate and estradiol

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	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

Secondary Outcome Measures

Name	Time	Method
Endometrial thickness on day of HCG administration	3 months	Endometrial thickness by TVS on day of HCG administration

Trial Locations

Locations (2)

Obstetrics and Gynecology Department in Mansoura University Hospital; 🇪🇬 Mansoura, Dakahlia, Egypt

Private practice settings; 🇪🇬 Mit Ghamr, Dakahlia, Egypt