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The basis for obesity's impact on reproduction is not well characterised and there is a controversy whether the key organ influenced by it are the ovaries or the uterus.
Insulin sensitizers ameliorate insulin resistance in obese patients. This study seeks to determine if Metformin helps to increase fecundability by affecting the uterus in women undergoing ART. As a surrogate marker- flows in the uterus will be tested during the treatment.
Obesity has been long implicated in reduced reproductive potential and it has been shown to impair conception and implantation. However, the basis for this adverse effect is still obscure and there is a controversy whether the key organ influenced by it are the ovaries or the uterus.
It is well established that insulin resistance is one of the main mechanisms of obesity's negative influences on the reproductive organs in females. Insulin sensitizers ameliorate insulin resistance in obese patients.
This study seeks to determine if Metformin ,an oral antidiabetic and insulin sensitizer, helps to increase fecundability by affecting the uterus in women undergoing frozen-thawed embryo transfer compared to the control group. As a surrogate marker- flows in the uterus will be tested during the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Active Comparator | drug: metformin |
|
| control | No Intervention | without metformin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Supplementation of the study group with Metformin till the day of pregnancy confirmation |
|
| Measure | Description | Time Frame |
|---|---|---|
| pregnancy rate | until the blood test for pregnancy, about 4-6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in Doppler blood flow indices in both uterine arteries | until the blood test for pregnancy, about 4-6 weeks | |
| endometrial thickness change measured by millimeters | until the blood test for pregnancy, about 4-6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| nora gorhad shabso, doctor | Contact | ngorhad@poria.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| JOHNNY YOUNIS, PEOFESSOR | Head of Fertility unit, Poriya' Bar Ilan University | Principal Investigator |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Endometrial Doppler flows measured by power doppler - percentage of endometrium with flows | until the blood test for pregnancy, about 4-6 weeks |
| D000091662 | Genital Diseases |
| D007246 | Infertility |