Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of administration of low dose of human chorionic gonadotropin (HCG) after use of clomiphene citrate (CC) for induction of ovulation in infertile women having CC resistant polycystic ovarian syndrome (PCOS).

Detailed Description
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Women will be randomly divided into two groups; CC-HCG group and CC group. Women in the CC-HCG group will receive CC (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle). Women in the CC group will receive CC alone (150 mg/day 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 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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Use of Low Dose of Human Chorionic Gonadotropin During Ovulation Induction With Clomiphene Citrate in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome

Conditions
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Infertility, Polycystic Ovarian Syndrome

Intervention / Treatment
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* Drug: Clomiphene citrate and Human chorionic gonadotropin (HCG)
* Drug: Clomiphene citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infertile lean women with PCOS as defined by the Rotterdam criteria. CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles). Exclusion Criteria: Age < 20 or > 35 years. Presence of any infertility factor other than anovulatory PCOS. Previous history of ovarian surgery or surgical removal of one ovary. Previous exposure to cytotoxic drugs or pelvic irradiation. Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months. Metabolic or hormonal abnormalities.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clomiphene citrate-HCG group<br>Women will receive clomiphene citrate and human chorionic gonadotropin (HCG) | Drug: Clomiphene citrate and Human chorionic gonadotropin (HCG)<br>* Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle)<br>* Other names: Clomid and Choriomon;|
| Active Comparator: Clomiphene citrate group<br>Women will receive clomiphene citrate alone | Drug: Clomiphene citrate<br>* Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle)<br>* Other names: Clomid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulation rate | Number of ovulatory cycles divided by the number of stimulation cycles | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ovarian follicles ≥ 18 mm on day of triggering of oocyte maturation | Number of ovarian follicles ≥ 18 mm by TVS on day of triggering of oocyte maturation | 3 months | 
| Endometrial thickness on day of triggering of oocyte maturation | Endometrial thickness by Transvaginal sonography (TVS) scan on day of triggering of oocyte maturation | 3 months | 
| 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 | 
| Incidence of early ovarian hyperstimulation syndrome (OHSS) | Incidence of OHSS within 9 days of final triggering of oocyte maturation | Within 9 days of final triggering of oocyte maturation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, Clomiphene citrate resistant, HCG