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Investigators will evaluate and compare the efficacy of Sitagliptin/Metformin to metformin and sitagliptin on gdf9 and bmp15 gene expression on PCOS patients undergoing intracytoplasmic sperm injection(ICSI).
This study was conducted in Infertility clinic of Mahdiyeh Educational Hospital, Tehran. Patients in the four groups receive the drug 2 months before the start of the ovulation cycle, and treatment will continue until the day of the oocyte aspiration. The drug provide by midwife to patients and both patient and physician blind to the treatment regimen. The participants randomly divide into four groups.The ovulation induction stimulate with GnRh antagonist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily |
|
| Metformin | Experimental | Intervention group 1: received Metformin (Glucophage, Merck, West Drayton, UK; 500 mg ,two times daily |
|
| Sitagliptin | Experimental | Intervention group2: received Sitagliptin (Januvia, Merck,West Drayton, UK. 50 mg, two times daily |
|
| sitagliptin/metformin | Experimental | Intervention group3: received Sitagliptin/metformin (Janumet, Merck,West Drayton, UK. 50/500 mg), two times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | Oral rehydration solution |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting insulin | ELIZA hormone assay | 24 hours after last dose |
| Growth differentiation factor-9(GDF-9) expression | Realtime PCR | 24 hours after last dose |
| Bone morphogenetic protein-15(BMP-15) expression | Realtime PCR | 24 hours after last dose |
| Total Testosterone | ELIZA hormone assay | 24 hours after last dose |
| Follicle-stimulating hormone(FSH) | ELIZA hormone assay | 24 hours after last dose |
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Inclusion Criteria:
Exclusion Criteria:
Study is based women with polycystic ovary syndrome.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Delbar Daneshjou, PHD student | Contact | 989120823342 | db.daneshjou@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shahrzad Shahrzad Zadehmodarres, Professor | Shahid Beheshti University of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mahdiyeh educational hospital | Recruiting | Tehran | 1989930002 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32720198 | Derived | Daneshjou D, Zadeh Modarres S, Soleimani Mehranjani M, Shariat Zadeh SMA. Comparing the effect of sitagliptin and metformin on the oocyte and embryo quality in classic PCOS patients undergoing ICSI. Ir J Med Sci. 2021 May;190(2):685-692. doi: 10.1007/s11845-020-02320-5. Epub 2020 Jul 28. |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D015532 | Rehydration Solutions |
| D008687 | Metformin |
| D000068900 | Sitagliptin Phosphate |
| D000068899 | Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination |
| ID | Term |
|---|---|
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D001645 | Biguanides |
| D006146 | Guanidines |
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| metformin | Drug | metformin tablet |
|
|
| Sitagliptin | Drug | Sitagliptin tablet |
|
|
| Sitagliptin/metformin | Drug | Sitagliptin/metformin tablet |
|
|
| 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 |
| D000578 |
| Amidines |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D004338 | Drug Combinations |