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

PAEC general hospital

Status and phase: Completed; Phase 3

Conditions: PCOS (Polycystic Ovary Syndrome)

Treatments: Drug: Myoinositol; Drug: Metformin 1500 mg daily

Study type: Interventional

Funder types: Other

Identifiers

NCT07323589

PGHI-IRB(DME)-RCD-06-097

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

arm 1

Experimental group

Description:

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

Treatment:

Drug: Myoinositol

arm 2

Experimental group

Description:

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

Treatment:

Drug: Metformin 1500 mg daily

Drug: Myoinositol