Impact of Myo-Inositol Alone vs Myo-Inositol Plus Metformin on Conception, Adherence, and Tolerability in PCOS
Status:
COMPLETED
Trial end date:
2025-10-25
Target enrollment:
Participant gender:
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/m) 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.