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Insulin resistance (IR) in men may be the underlying pathogenesis for metabolic abnormalities and chronic hypospermatogenesis similar to women with polycystic ovarian disease (PCOD). Infertile men with unexplained infertility and IR may benefit from treatment with metformin.
Recently insulin resistance (IR) has been recognized as the underlying pathogenesis of chronic anovulation, hyperandrogenism, and metabolic abnormalities associated with PCOD in women. IR could be the underlying pathogenesis of chronic hypospermatogenesis leading to oligospermia and azoospermia associated with other metabolic abnormalities in men. Metformin has proven as an effective medication for not only IR but several other aspects of the PCOD including reproductive abnormalities. Therefore, insulin sensitizers, particularly metformin can be introduced as a pharmaceutical option for unexplained oligozoospermia and azoospermia associated with insulin resistance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin / clomid / hCG | Experimental | Metformin 1000 mg orally to be given daily for one week then twice daily for 2 weeks then 3 times daily for 6 months. After 3 months from starting metformin the participant will receive 2 more medications in addition to metformin: Clomid 50 mg orally per day and 5000 IU human chorionic gonadotrophin (hCG ) IM once per week for three months. |
|
| Clomid / hCG | Experimental | Clomid 50 mg per day will be administered orally and human chorionic gonadotrophin ( choriomon ) 5000 IU will be administered IM once per week. Both medications will be given for 6 month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin / clomid / hCG | Drug | Metformin 1000 mg daily for a week then twice daily for 2 weeks then 3 tomes daily for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| sperm count | semen analysis before the start of metformin and then every month for 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| abnormal forms of spermatozoa | semen analysis before the start of metformin and then every month for 6 months | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ragaa mansour, MD,PhD | The Egyptian IVF-ET Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Egyptian IVF-ET center | Recruiting | Cairo | Cairo Governorate | 11431 | Egypt |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D007333 | Insulin Resistance |
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D002996 | Clomiphene |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D013267 |
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| Clomiphene citrate / hCG | Drug | Clomiphene citrate 50 mg daily for one month, then twice daily for 2 months then 3 times per day for 3 months. |
|
|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |