Comparison of new progestin based IVF treatment with standard GnRH antagonist based IVF treatment in Polycystic ovarian syndrome (PCOS) wome
Phase 3
- Conditions
- Health Condition 1: E282- Polycystic ovarian syndrome
- Registration Number
- CTRI/2024/07/071226
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
BMI less than 35kg/m2 with PCOS diagnosed as per the International PCOS guidelines. Diagnosis of PCOS is made if after excluding other causes of irregular menstrual cycle and hyperandrogenism, any two of the following is present:
1. Irregular menstrual cycles-oligomenorrhoea/ amenorrhoea;
2. Clinical/biochemical hyperandrogenism;
3. Polycystic ovarian morphology –Defined on TVS as (FNPO) follicle number per ovary equals/ exceeds 20 in atleast one ovary.
Exclusion Criteria
Grade 3 or higher endometriosis
Uterine anomalies, fibroid or adenomyoma distorting the endometrial cavity
Uncontrolled thyroid and/or prolactin disorders
Not willing to participate in study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Premature LH surge and <br/ ><br>Oocyte yield <br/ ><br>Timepoint: 4-5 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method Total dose of gonadotropins required <br/ ><br>Duration of controlled ovarian stimulation <br/ ><br>Peak serum estradiol (E2), progesterone (P4) and luteinizing hormone (LH) level on the day of trigger <br/ ><br>Number of total/MII oocytes retrieved <br/ ><br>FORT (Follicular output rate) <br/ ><br>FOI (follicular oocyte index) <br/ ><br>Fertilization rate <br/ ><br>Cleavage rate <br/ ><br>Clinical pregnancy rate <br/ ><br>Incidence of OHSS <br/ ><br>Timepoint: 2 years