Adding Prednisolone During Ovulation Induction With CC in Lean 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 concomitant administration of prednisolone during use of clomiphene citrate (CC) for induction of ovulation in infertile lean women having CC resistant polycystic ovarian syndrome (PCOS).

Detailed Description
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Women will be randomly divided into two groups; CC-Prednisolone group and CC-placebo group. Women in the CC-Prednisolone group will receive CC (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone tablet (5 mg/day for 10 consecutive days from day 2 of the cycle). Women in the CC-placebo group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid tablet (0.5 mg/day for 10 consecutive days from day 2 of the 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 mid-luteal 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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Adding Prednisolone During Ovulation Induction With Clomiphene Citrate in Lean 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 Prednisolone
* Drug: Clomiphene citrate and folic acid


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. Body mass index (BMI) < 18.5 kg/m2 or > 25 kg/m2. 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-Prednisolone group<br>Women will receive clomiphene citrate and prednisolone | Drug: Clomiphene citrate and Prednisolone<br>* Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone (5 mg/day for 10 consecutive days from day 2 of the cycle)<br>* Other names: Clomid and Hostacortin-H;|
| Active Comparator: Clomiphene citrate-placebo group<br>Women will receive clomiphene citrate and folic acid 0.5mg (placebo) | Drug: Clomiphene citrate and folic acid<br>* Women will receive clomiphene citrate alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid (0.5 mg/day for 10 consecutive days from day 2 of the cycle)<br>* Other names: Clomid and folic acid;|

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 HCG administration | Number of ovarian follicles ≥ 18 mm by TVS on day of HCG administration | 3 months | 
| Endometrial thickness on day of HCG administration | Endometrial thickness by TVS on day of HCG administration | 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 | 

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