Comparison of Clomid and Lezra with Lezra for Ovulation Induction in Clomid Resistant PCOS Case

Phase 1

Recruiting

• Conditions: Polycystic Ovarian Syndrome
• Interventions: Drug: Clomiphene Citrate and letrozole

• Registration Number: NCT06813118
• Lead Sponsor: HITEC-Institute of Medical Sciences

Brief Summary

Clomiphene citrate resistant i.e failure to ovulate after 6 cycles of ovulation induction effects 15-40% of patients with PCOS.Two treatment groups will be formed one recieving letrozole alone and another recieving CC and letrozole combined.Mature follicles and endometrial thickness will be checked by transvaginal ultrasound and results will be recorded.

Detailed Description

Subfertility is characterized by the inability to achieve conception despite engaging in regular unprotected sexual intercourse for 1-2 years.PCOS exhibits chacteristic traits such as obesity,heightened insulin resistance accompanied by compensatory hyperinsulinemia,oligo/anovulation and subfertility.Clompiphene citrate induces ovarian stimulation.Letrozole ,an aromatase inhibitor emerges as a novel medication with comparable efficacy to CC as a first line treatment for inducing ovulation in cases of anovulation.

Study Timeline

• Study Start: 2024-06-07
• Study First Submitted: 2024-09-13
• Status Verified: 2025-02
• Primary Completion: 2025-02
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

• women of 20-40 years with a history of PCOS and resistant to CC

Exclusion Criteria

• Premature ovarian insufficiency
• Husband has oligo azoospermia
• Hypothyroidism
• Hyperprolactinemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	Clomiphene Citrate and letrozole	clomiphene citrate and letrozole combination
group 2	Clomiphene Citrate and letrozole	letrozole alone

Primary Outcome Measures

Name	Time	Method
To compare the rate of ovulation	6 months	To compare the rate of ovulation between letrozole alone and letrozole and CC

Trial Locations

Locations (1)

HIT Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan