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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm 1 | Experimental | in the comparison group of study: Researchers will compare Group A (myo-inositol 4 g/day) |
|
| arm 2 | Experimental | group B will be a combination group (Metformin 1500mg per day and Myo inositol 4gram per day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myoinositol | Drug | myo-inositol (4 g/day) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Confirmed Clinical Pregnancy by Ultrasound | Clinical pregnancy defined as the presence of a gestational sac confirmed by ultrasound. | Up to 6 months or until pregnancy is confirmed |
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Inclusion Criteria:
Exclusion Criteria:
females of reproductive age group
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| Name | Affiliation | Role |
|---|---|---|
| Maria Amin | PAEC general hospital, H-11/4, islamabad | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAEC general hospital | Islamabad | Isb | 440000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30614289 | Result | 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. | |
| Result | 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 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Dec 23, 2025 | Dec 22, 2025 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D007294 | Inositol |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| Metformin 1500 mg daily |
| Drug |
metfromin plus myoinositol 1500mg and 4gram per day respectively |
|
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D001645 |
| Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |