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The goal of this clinical trial is to evaluate and compare the effectiveness of combined Myoinositol and Metformin therapy versus a combination of Pioglitazone and Metformin, and Metformin alone in infertile women with Polycystic Ovary Syndrome (PCOS) undergoing Intracytoplasmic Sperm Injection (ICSI). The main questions it aims to answer are:
Participants will:
The percentage of oocytes reaching the second meiotic division will be evaluated, indicating the readiness for fertilization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Active Comparator | Group I (n=50 PCOS patients) will be as the controlled group and receive metformin monotherapy. |
|
| Group II | Experimental | Group II (n=50 PCOS patinets) will receive combination of Myoinositol at a dosage of 600 mg administered twice daily and metformin 850 mg tablets once daily for one month prior to undergoing Intracytoplasmic Sperm Injection (ICSI) |
|
| Group III | Experimental | Group III (n=50 PCOS patients) will receive a combination of pioglitazone 15 mg and metformin 850 mg tablets once daily for one month before ICSI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin monotherapy | Drug | metformin 850 mg tablets once daily for one month before ICSI |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Fertilization rate | the percentage of fertilized oocytes the specified timeframe will be assessed. | 3 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Abortion rate | The percentage of clinical pregnancies that result in spontaneous miscarriage prior to the 20-week gestation mark will be evaluated to assess the stability of pregnancies achieved. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
female patients diagnosed with PCOS are eligible for participation in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-Suef University Hospital | Banī Suwayf | Beni Suweif Governorate | 62521 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38374053 | Background | Zhao H, Zhang J, Xing C, Cheng X, He B. Metformin versus metformin plus pioglitazone on gonadal and metabolic profiles in normal-weight women with polycystic ovary syndrome: a single-center, open-labeled prospective randomized controlled trial. J Ovarian Res. 2024 Feb 19;17(1):42. doi: 10.1186/s13048-024-01367-7. |
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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 |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| Myoinositol and metformin |
| Combination Product |
Myoinositol at a dosage of 600 mg administered twice daily and metformin 850 mg tablets once daily for one month prior to undergoing Intracytoplasmic Sperm Injection (ICSI) |
|
| pioglitazone and metformin | Combination Product | A combination of pioglitazone 15 mg and metformin 850 mg tablets once daily for one month before ICSI. |
|
| 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 |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |