NCT07323589

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

Impact of Myo-Inositol vs Combined Myo-Inositol and Metformin Therapy on Conception Rates, Treatment Adherence, and Tolerability in Overweight Women Diagnosed With PCOS: A Randomized Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: PAEC general hospital · Other Government
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Myoinositol	myo-inositol (4 g/day)
DRUG	Metformin 1500 mg daily	metfromin plus myoinositol 1500mg and 4gram per day respectively

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-07-30
• Completion: 2025-10-25
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: Pakistan