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To study the effect of surgery in infertile PCOS women taking fertility treatment

Randomised controlled trial to study the effect of ovarian drilling versus step up gonadotropin therapy in anovulatory infertile PCOS women undergoing ovulation induction cycles

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/052083
Enrollment
70
Registered
2023-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

Intervention1: Laparoscopic ovarian drilling: laparoscopic ovarian drilling will be done with drilling done with 4-5 punctures in each ovary using 40W cutting current for 4 seconds for each drill Cont

Sponsors

All India Institute of Medical Sciences, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • PCOS women with anovulatory infertility (Phenotype A,B and D) diagnosed according to Rotterdam criteria • Age 19-38 years • At least one patent tube documented on either HSG/laparoscopy • AMH levels >6ng/ml • No follicular response to Letrozole 5mg+75IU HMG till day 14 • BMI =35kg/m2

Exclusion criteria

Exclusion criteria: 1.AMH = 6 ng /dl 2.BMI > 35 kg/m2 3.Moderate to severe male factor infertility 4.Endometriosis.

Design outcomes

Primary

MeasureTime frame
Development of dominant follicle (16mm)Timepoint: baseline, one month, 2 month

Secondary

MeasureTime frame
clinical pregnancy rate/ongoing pregnancy rateTimepoint: one month, 2 months, 3months;effect of laparoscopic ovarian drilling on Hormonal parameters (AMH, serum testosterone) -Metabolic parameters (Fasting insulin, fasting blood sugar, lipid profile, HOMA-IR) Timepoint: baseline, one month

Countries

India

Contacts

Public ContactReeta Mahey

All Indian Institute Of Medical Sciences, New Delhi

reetamahey52@gmail.com09818447845

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026