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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07323589

Enrollment

120

Registered

2026-01-07

Start date

2025-01-01

Completion date

2025-10-25

Last updated

2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PCOS (Polycystic Ovary Syndrome)

Keywords

Myo-inositol, Polycystic Ovary Syndrome

Brief 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.

Interventions

DRUGMyoinositol

myo-inositol (4 g/day)

DRUGMetformin 1500 mg daily

metfromin plus myoinositol 1500mg and 4gram per day respectively

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 35 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with Confirmed Clinical Pregnancy by Ultrasound	Up to 6 months or until pregnancy is confirmed	Clinical pregnancy defined as the presence of a gestational sac confirmed by ultrasound.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026