To see various factors which help or hamper in the development of dominant follicle in females with polycystic ovarian disease with tablet Letrozole .

Phase 3

• Conditions: Health Condition 1: E282- Polycystic ovarian syndrome

• Registration Number: CTRI/2023/10/058821
• Lead Sponsor: All India Institute of Medical Sciences Department of Obstetrics and Gynaecology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Infertile women (1 year of regular unprotected intercourse without conception)

2. Age 21 to 38 years

3. Diagnosed with PCOS as per modified Rotterdam criteria (28)

4. Normal husband semen parameters as per sixth edition WHO semen analysis 2021 criteria (29)

5. At least one patent tube confirmed by hysterosalpingography/ sono-salpingography / laparoscopy

6. Not on insulin sensitizers in last 3 months

7. Willing to participate in the study and follow up

Exclusion Criteria

1. Infertility due to causes other than anovulation

2. Endometrioma/endometriosis

3. Diminished ovarian reserve (AMH <1.5 ng/ml, antral follicle count(AFC) <7, FSH >10 IU/ml)

4. Patient with thyroid disorder, hyperprolactinemia

5. H/o laparoscopic ovarian drilling or any ovarian surgery in past 6 months

6. Females with chronic illness such as seizure disorder, diabetes mellitus, chronic kidney disease, chronic liver disease etc.

7. Any active infection such as pelvic inflammatory disease, tuberculosis, upper respiratory tract infection etc.

8. Not willing for ovulation induction

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of at least one follicle more than 16mm diameterTimepoint: Development of at least one follicle more than 16mm diameter by day 12 of last mestrual period

Secondary Outcome Measures

Name	Time	Method
1. Correlation of development of dominant follicle with clinical, endocrine, metabolic & sonographic factors among various PCOS phenotypes. <br/ ><br>2. Incidence of luteinized unruptured follicle with letrozole therapy <br/ ><br>3. Clinical pregnancy rate (UPT positive/presence of at least one intrauterine gestational sac in uterine cavity on ultrasonography at 5 weeks) <br/ ><br>4. Cycle cancellation rate- No development of dominant follicle despite all protocols <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: Till 3 cycles <br/ ><br> <br/ ><br>