MedTrace Logo

Impact of Myo-Inositol Alone vs Myo-Inositol Plus Metformin on Conception, Adherence, and Tolerability in PCOS

NCT07323589 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-01-07

No results posted yet for this study

Summary

The goal of this clinical trial (prospective randomized controlled trial) is to compare whether myo-inositol alone or in combination with metformin can improve conception rates, treatment compliance, and side-effect profiles in overweight women (BMI ≥25 kg/m²) diagnosed with polycystic ovary syndrome (PCOS).

The main questions it aims to answer are:

1. Does myo-inositol alone achieve conception rates comparable to the combination of myo-inositol and metformin?
2. Does the combination therapy result in more side effects and lower compliance compared to myo-inositol alone? If there is a comparison group: Researchers will compare Group A (myo-inositol 4 g/day) with Group B (myo-inositol 4 g/day + metformin 1500 mg/day) to see if the addition of metformin improves conception outcomes but at the cost of tolerability.

Participants will:

* Be randomly assigned to receive either myo-inositol alone or myo-inositol plus metformin for six months.
* Attend follow-up visits for monitoring of pregnancy outcomes confirmed by ultrasound.
* Report any side effects experienced during treatment.
* Provide information on treatment adherence and dropout rates.
* Be assessed for menstrual regularity and ovulation rates.

Conditions

  • PCOS (Polycystic Ovary Syndrome)

Interventions

DRUG

Myoinositol

myo-inositol (4 g/day)

DRUG

Metformin 1500 mg daily

metfromin plus myoinositol 1500mg and 4gram per day respectively

Sponsors & Collaborators

  • PAEC general hospital

    lead OTHER_GOV

Principal Investigators

  • Maria Amin · PAEC general hospital, H-11/4, islamabad

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-07-30
Completion
2025-10-25

Countries

  • Pakistan

Study Locations

More Related Trials

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 NCT07323589 on ClinicalTrials.gov