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Completed

NCT Number: NCT07635082

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

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

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Key information

Conditions

Polycystic Ovary Syndrome (PCOS) Women Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Kafrelsheikh University Hospital

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria.
  • Letrozole-resistant PCOS patients who failed to ovulate after receiving letrozole 5 mg daily for 5 days for three consecutive cycles.
  • Age 18 to 35 years.
  • Body mass index (BMI) ≤ 30 kg/m².
  • Normal uterine cavity and patent fallopian tubes confirmed by hysterosalpingography (HSG) and/or laparoscopy.
  • Partner with normal semen analysis.
  • Willing and able to provide informed consent.

Exclusion criteria

  • Thyroid dysfunction.
  • Hyperprolactinemia.
  • Diabetes mellitus.
  • Congenital adrenal hyperplasia.
  • Adrenal causes of hyperandrogenism.
  • Use of insulin-sensitizing medications (e.g., metformin) during the study period.
  • Chronic liver disease.
  • Chronic kidney disease.
  • Contraindications to pregnancy.
  • Contraindications or hypersensitivity to inositol or letrozole.

Treatment and study plan

ELP (Extended Letrozole Protocol)

Drug

? 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.

LIP (Letrozole + Inositol Protocol)

Drug

? 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.

Primary outcomes

  1. Ovulation Rate

    Time frame: At the end of Cycle 1 (each treatment cycle is 28 days).

    The proportion of participants achieving ovulation after treatment with either an extended letrozole protocol (5 mg daily for 7 days) or letrozole plus inositol protocol in letrozole-resistant PCOS women.

Secondary outcomes

  1. Spontaneous Ovulation Rate

    Time frame: Up to 3 months after treatment initiation.

    The proportion of participants who achieve spontaneous ovulation during the study period.

  2. Clinical Pregnancy Rate

    Time frame: Up to 12 weeks after treatment initiation.

    The proportion of participants with clinical pregnancy confirmed by transvaginal ultrasonographic visualization of a gestational sac.

Sponsors and collaborators

Lead sponsor

Eman Basuni Ebrahim Mowad

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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