Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PCOS (Polycystic Ovary Syndrome) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin 1500 mg daily | Drug | Metformin | ALIAS |
| Myoinositol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- arm 1
- description
- in the comparison group of study: Researchers will compare Group A (myo-inositol 4 g/day)
- interventionNames
- Drug: Myoinositol
- type
- EXPERIMENTAL
- label
- arm 2
- description
- group B will be a combination group (Metformin 1500mg per day and Myo inositol 4gram per day)
- interventionNames
- Drug: Myoinositol
- Drug: Metformin 1500 mg daily
Primary outcomes (1)
- measure
- Number of Participants with Confirmed Clinical Pregnancy by Ultrasound
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 35 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTAgrawal 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. PMID 30614289
- RESULTThakur 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