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Inositol in Letrozol Resistant PCOS Women

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07585396
Enrollment
36
Registered
2026-05-13
Start date
2025-05-10
Completion date
2026-05-11
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome, Letrozol Resistant

Keywords

Inositol, Letrozol, PCOS

Brief summary

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.

Detailed description

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).

Interventions

Combined myoinositol \& Dchiroinositol twice daily plus letrozole for 3 months

DRUGMetformin

Metformin 500mg twice daily plus letrozole for 3 months

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

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 .

Design outcomes

Primary

MeasureTime frame
Ovulation rate confirmed by folliculometry measured by transvaginal ultrasound3 months after taaking letrozole only for 3 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026