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

NCT07635082 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-06-09

No results posted yet for this study

Summary

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

Conditions

  • Polycystic Ovary Syndrome (PCOS) Women
  • Polycystic Ovary Syndrome

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.

Sponsors & Collaborators

  • Eman Basuni Ebrahim Mowad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2025-06-01
Completion
2025-07-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07635082 on ClinicalTrials.gov