Concomitant CC and E2 Versus CC Alone in Ovulation Induction

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility, Anovulation

Intervention / Treatment
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* Drug: Clomiphene citrate and Estradiol
* Drug: Clomiphene citrate and Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clomiphene citrate-Estradiol group<br>Women will receive clomiphene citrate and estradiol | Drug: Clomiphene citrate and Estradiol<br>* Women will receive clomiphene citrate (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)<br>* Other names: Clomid and Estradiol valerate;|
| Active Comparator: Clomiphene citrate group<br>Women will receive clomiphene citrate and placebo | Drug: Clomiphene citrate and Placebo<br>* Women will receive clomiphene citrate (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo (for 5 consecutive days from day 2 of cycle)<br>* Other names: Clomid and Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | 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 | 6-8 weeks gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometrial thickness on day of HCG administration | Endometrial thickness by TVS on day of HCG administration | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clomiphene citrate, Estradiol, Endometrial thickness