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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-10-25

Brief Summary

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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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Detailed Description

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Conditions

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PCOS (Polycystic Ovary Syndrome)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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arm 1

in the comparison group of study: Researchers will compare Group A (myo-inositol 4 g/day)

Group Type EXPERIMENTAL

Myoinositol

Intervention Type DRUG

myo-inositol (4 g/day)

arm 2

group B will be a combination group (Metformin 1500mg per day and Myo inositol 4gram per day)

Group Type EXPERIMENTAL

Myoinositol

Intervention Type DRUG

myo-inositol (4 g/day)

Metformin 1500 mg daily

Intervention Type DRUG

metfromin plus myoinositol 1500mg and 4gram per day respectively

Interventions

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Myoinositol

myo-inositol (4 g/day)

Intervention Type DRUG

Metformin 1500 mg daily

metfromin plus myoinositol 1500mg and 4gram per day respectively

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No