NCT07323589CompletedPhase 3
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
Source: ClinicalTrials.gov · Last updated 7 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 14 Nov 2025
- Start date
- 1 Jan 2025
- Primary completion date
- 30 Jul 2025
- Lead sponsor
- PAEC general hospital
- NCT number
- NCT07323589
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 120
- From 1 Jan 2025 to the primary completion date, 30 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Pregnant or breastfeeding
Who the study is looking for
- 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
Age in the registry: 20 years to 35 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PAEC general hospital Coordinator of this site? Confirm its status | Islamabad | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.