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Hypothesis: Prescribed clomiphene citrate to azoospermic patients with hypoandrogenism could improve the sperm retrieval in either fresh sperm or after surgical sperm extraction.
Hypogonadism (low testosterone level) is frequently observed in men presenting with non obstructive azoospermia. Controversy exists regarding the efficacy of preoperative hormonal manipulation in patients with hypogonadism. However, it is possible that hormonal therapy increases intra-testicular testosterone levels, and with a rise in serum testosterone, sperm production and surgical success with microTESE improve.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clomiphene citrate | Active Comparator | Clomiphene citrate 50 mg daily during 4-6 months |
|
| Placebo | Placebo Comparator | Placebo (1 pill daily) during 4-6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clomiphene | Drug | Clomiphene citrate 50 mg orally daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of sperm in the ejaculated or in the microsurgical testicular Sperm extraction (microTESE) | After four months of clomiphene treatment | |
| Epigenetic modifications | After four months of clomiphene treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Testosterone levels and Bioavailable Testosterone levels | After two weeks and four months with clomiphene treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saturnino Luján, MD, PhD | University of Valencia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Valencia | Valencia | Province of Valencia | 46010 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16291975 | Result | Hussein A, Ozgok Y, Ross L, Niederberger C. Clomiphene administration for cases of nonobstructive azoospermia: a multicenter study. J Androl. 2005 Nov-Dec;26(6):787-91; discussion 792-3. doi: 10.2164/jandrol.04180. | |
| 22958644 | Result | Hussein A, Ozgok Y, Ross L, Rao P, Niederberger C. Optimization of spermatogenesis-regulating hormones in patients with non-obstructive azoospermia and its impact on sperm retrieval: a multicentre study. BJU Int. 2013 Mar;111(3 Pt B):E110-4. doi: 10.1111/j.1464-410X.2012.11485.x. Epub 2012 Sep 7. |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D053713 | Azoospermia |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D007248 | Infertility, Male |
| D005832 | Genital Diseases, Male |
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| ID | Term |
|---|---|
| D002996 | Clomiphene |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo | Drug | One pill every other day |
|
|
| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
| D052801 | Male Urogenital Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |