A clinical trial to compare the clinical, metabolic and hormonal parameters amongst the women who respond to the ovulation induction drug clomiphene citrate and those who do not.
Not Applicable
Completed
- Conditions
- Health Condition 1: null- PCOS related infertility
- Registration Number
- CTRI/2018/03/012640
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 164
Inclusion Criteria
1. Women with PCOS related infertility based on Rotterdamâ??s criteria.
2. Age less than 40 yrs.
3. Normal serum prolactin and thyroid function tests.
Exclusion Criteria
1. Patient is on any insulin-sensitizing agent or any lipid-lowering agent or any other drugs
2. Presence of any other endocrine disorder
3. Presence of anorexia nervosa or bulimia nervosa or any hypothalamic or pituitary dysfunction.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ovulation with Clomiphene CitrateTimepoint: At day 10-11 of each cycle, trans-vaginal ultrasound done to look for the formation of dominant follicle. This is repeated for three consecutive cycles after ovulation induction with 50 mg, 100 mg and 150 mg clomiphene citrate.
- Secondary Outcome Measures
Name Time Method 1. Dose at which ovulation occurred. (50 mg/100 mg/150 mg) <br/ ><br>2.Dose at which conception occurred. (50 mg/100 mg/150 mg). <br/ ><br>3. Comparison between different PCOS phenotypes.Timepoint: 1. Transvaginal scan done on day 10-11 of each cycle to look for the formation of the dominant follicle after ovulation induction with 50 mg/ 100 mg/150 mg Clomiphene Citrate. <br/ ><br>2. Conception recorded with urine pregnancy test or ultrasound during this period of 3 months.