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COMPLETED
NCT07635082
PHASE2

Extended Letrozole Protocol Versus Letrozole Plus Inositol for Induction of Ovulation in Letrozole Resistant PCOS Women

Sponsor: Eman Basuni Ebrahim Mowad

View on ClinicalTrials.gov

Summary

Extended letrozole protocol versus letrozole plus Inositol for Induction of ovulation in letrozole resistant PCOS Women

Key Details

Gender

FEMALE

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-02-01

Completion Date

2025-07-01

Last Updated

2026-06-09

Healthy Volunteers

No

Interventions

DRUG

ELP (Extended Letrozole Protocol)

? ELP (Extended Letrozole Protocol) Participants allocated to this arm will receive letrozole 5 mg orally once daily, starting on day 2 of the menstrual cycle and continued for 7 consecutive days. Follicular development will be monitored using transvaginal ultrasonography every 48 hours starting after the last dose of letrozole until confirmation of ovulation. When at least one dominant follicle reaches a mean diameter of 18-20 mm, human chorionic gonadotropin (hCG) will be administered to trigger ovulation. Timed intercourse will be advised accordingly. Endometrial thickness will be measured on the day of ovulation trigger. This protocol may be repeated for up to 3 consecutive cycles in case ovulation is not achieved.

DRUG

LIP (Letrozole + Inositol Protocol)

? LIP (Letrozole + Inositol Protocol) Participants allocated to this arm will receive myo-inositol 2 g orally twice daily for a duration of 3 months prior to ovulation induction. In the subsequent cycle, letrozole 5 mg orally once daily will be administered starting on day 2 of the menstrual cycle for 5 consecutive days. Follicular monitoring will be performed using transvaginal ultrasonography every 48 hours after the last dose of letrozole until ovulation is confirmed. Ovulation will be triggered using hCG injection when at least one follicle reaches 18-20 mm in diameter, followed by timed intercourse. Compliance with inositol intake and any adverse effects will be documented throughout the study period.

Locations (1)

Kafrelsheikh University Hospital

Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt