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OpenTrials
Completed

NCT Number: NCT07323589

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women aged 20 to 35 years
  • BMI ≥25 kg/m²
  • Fulfilled at least two of the three Rotterdam criteria for PCOS
  • Attempting to conceive naturally
  • No use of hormonal drugs or insulin-sensitizers in the past three months

Exclusion criteria

  • Endocrine disorders (e.g., diabetes, thyroid dysfunction)
  • Hepatic impairment
  • Kidney disease
  • Gastrointestinal or malabsorption issues (IBS, IBD, celiac disease)
  • Known allergies to metformin or inositol
  • Pregnant or breastfeeding

Treatment and study plan

Myoinositol

Drug

myo-inositol (4 g/day)

Metformin 1500 mg daily

Drug

metfromin plus myoinositol 1500mg and 4gram per day respectively

Primary outcomes

  1. Number of Participants with Confirmed Clinical Pregnancy by Ultrasound

    Time frame: Up to 6 months or until pregnancy is confirmed

    Clinical pregnancy defined as the presence of a gestational sac confirmed by ultrasound.

Sponsors and collaborators

Lead sponsor

PAEC general hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2026
Registry last updated
Jan 7, 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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