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

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.

Timeline

Start

2025-01-01

Primary completion

2025-07-30

Completion

2025-10-25

Publications

• Results Agrawal A, Mahey R, Kachhawa G, Khadgawat R, Vanamail P, Kriplani A. Comparison of metformin plus myoinositol vs metformin alone in PCOS women undergoing ovulation induction cycles: randomized controlled trial. Gynecol Endocrinol. 2019 Jun;35(6):511-514. doi: 10.1080/09513590.2018.1549656. Epub 2019 Jan 7.
• Results Thakur SS, Anjum S, Siddiqui SS. Randomised controlled trial: comparing effects of metformin versus myoinositol versus metformin and myoinositol on ovarian functions and metabolic factors in polycystic ovarian syndrome. Int J Reprod Contracept Obstet Gynecol. 2020;9(6):2542 50. doi:10.18203/2320-1770.ijrcog20202030

Drugs

Indications