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Completed

NCT Number: NCT07585396

Inositol in Letrozol Resistant PCOS Women

Polycystic ovary syndrome (PCOS),is a complex neuro-endocrine disorder affecting approximately 5% to 10% of women in reproductive age.Inositols are considered insulin sensitizers, as they modulate the members of insulin signaling pathways.Thiss study compares between the effect of inositol and metformin in letrozol resistant PCOS women.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Kafrelshiekh university hospital

Cairo, Egypt

About this study

Polycystic ovary syndrome (PCOS),is a complex neuro-endocrine disorder affecting approximately 5% to 10% of women in reproductive age .Furthermore, impaired glucose tolerance affects 30 - 40 % of women with PCOS and the pathophysiology of insulin resistance appears to be linked to a malfunction in the insulin signalling system. Insulin-sensitizing substances, including the B-complex vitamin inositol and its stereoisomers (myo-inositol and D-chiro-inositol )have therefore been investigated as a potential treatment for PCOS.

Letrozole is the recommended medication for ovulation induction in PCOS-related infertility since it produces higher pregnancy and live birth rates than Clomphine Citrate. Alternative regimens, such as two-step, higher, and prolonged doses, may be necessary for women who are not responding to the standard letrozole dosage. However, some women might not respond to letrozole even at the highest dosage.

Inositols are produced by the human body and are a member of the vitamin B complex group.Inositols are considered insulin sensitizers, as they modulate the members of insulin signaling pathways. They positively influence menstrual cycle regularity, carbohydrate metabolism, and the clinical and laboratory symptoms of hyperandrogenism (e.g., free testosterone, total testosterone, SHBG).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Age between 18- 35 years old.
  • Diagnosis of PCOS according to Rotterdam criteria
  • Letrozole resistant cases.
  • Normal thyroid hormone level.
  • Normal prolactin hormone level.

Exclusion criteria

  • • History of ovarian surgery.
  • cases associated with endometriosis.
  • History of diabetes mellitus.
  • Allergy to myo-Inositol .

Treatment and study plan

Myoinositol

Drug

Combined myoinositol & Dchiroinositol twice daily plus letrozole for 3 months

metformin

Drug

Metformin 500mg twice daily plus letrozole for 3 months

Primary outcomes

  1. Ovulation rate confirmed by folliculometry measured by transvaginal ultrasound

    Time frame: 3 months after taaking letrozole only for 3 months

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Efficacy of Inositol in Managing Subfertility in Letrozole-resistant Polycystic Ovary Syndrome Women

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 13, 2026
Registry last updated
Jun 17, 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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