NCT07585396

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2026

Completed
Last Updated

July 29, 2026

Status Verified

June 1, 2026

Enrollment Period

2.2 years

First QC Date

May 7, 2026

Last Update Submit

July 28, 2026

Conditions

Polycystic Ovary SyndromeInfertility

Keywords

InositolLetrozolPCOS

Outcome Measures

Primary Outcomes (1)

  • Cumulative Ovulation confirmed by folliculometry measured by transvaginal ultrasound

    5 months after taking letrozole only for 3 month

Study Arms (2)

Myoinositol group

ACTIVE COMPARATOR

Combined myoinositol twice daily for 3 months plus letrozole

Drug: Myoinositol

Metformin group

ACTIVE COMPARATOR

Metformin 500mg oral twice daily plus letrozole for 3 months

Drug: Metformin

Interventions

MyoinositolDRUG

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

Myoinositol group
MetforminDRUG

Metformin 500mg twice daily plus letrozole for 3 months

Metformin group

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20- 38 years old.
  • Diagnosis of PCOS according to Rotterdam criteria
  • Letrozole resistant cases.
  • Normal thyroid hormone level.
  • Normal prolactin hormone level.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelshiekh university hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeInfertility

Interventions

InositolMetformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesBiguanidesGuanidinesAmidines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 13, 2026

Study Start

April 10, 2024

Primary Completion

June 10, 2026

Study Completion

July 11, 2026

Last Updated

July 29, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)