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The goal of this clinical trial is to learn if drug clomiphene citrate improves sperm parameters in infertile men with idiopathic oligoasthenozoospermia. It will also learn about the safety of clomiphene citrate. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clomiphene | Experimental | Participants will receive Tab Clomiphene citrate 50 mg orally once daily or 12 weeks |
|
| Placebo | Placebo Comparator | Participants will receive Clomiphene citrate placebo tablet matching Clomiphene citrate orally once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clomiphene Citrate | Drug | 50 mg tab once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in sperm motility at 12 weeks | Sperm motility was percentage of progressive & non-progressive motility | Baseline and 12 weeks |
| Change from baseline in sperm count at 12 weeks | Sperm count was in million per milliliter of semen | Baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Male
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangabandhu Sheikh Mujib Medical University | Dhaka | 1200 | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25660648 | Background | Chehab M, Madala A, Trussell JC. On-label and off-label drugs used in the treatment of male infertility. Fertil Steril. 2015 Mar;103(3):595-604. doi: 10.1016/j.fertnstert.2014.12.122. Epub 2015 Feb 3. | |
| 25309854 | Background | Jung JH, Seo JT. Empirical medical therapy in idiopathic male infertility: Promise or panacea? Clin Exp Reprod Med. 2014 Sep;41(3):108-14. doi: 10.5653/cerm.2014.41.3.108. Epub 2014 Sep 30. |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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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
| Placebo | Drug | 1 tab once daily |
|
|
| 19707335 | Background | Cocuzza M, Agarwal A. Nonsurgical treatment of male infertility: specific and empiric therapy. Biologics. 2007 Sep;1(3):259-69. |
| 23970453 | Background | Chua ME, Escusa KG, Luna S, Tapia LC, Dofitas B, Morales M. Revisiting oestrogen antagonists (clomiphene or tamoxifen) as medical empiric therapy for idiopathic male infertility: a meta-analysis. Andrology. 2013 Sep;1(5):749-57. doi: 10.1111/j.2047-2927.2013.00107.x. |
| 37559276 | Background | Bridges N, Trofimenko V, Fields S, Carrell D, Aston K, Hotaling J. Male Factor Infertility and Clomiphene Citrate: A Meta-Analysis-The Effect of Clomiphene Citrate on Oligospermia. Urol Pract. 2015 Jul;2(4):199-205. doi: 10.1016/j.urpr.2014.10.007. Epub 2015 Apr 10. |
| 36680549 | Background | Huijben M, Huijsmans RLN, Lock MTWT, de Kemp VF, de Kort LMO, van Breda JHMK. Clomiphene citrate for male infertility: A systematic review and meta-analysis. Andrology. 2023 Sep;11(6):987-996. doi: 10.1111/andr.13388. Epub 2023 Jan 29. |
| 26235968 | Result | ElSheikh MG, Hosny MB, Elshenoufy A, Elghamrawi H, Fayad A, Abdelrahman S. Combination of vitamin E and clomiphene citrate in treating patients with idiopathic oligoasthenozoospermia: A prospective, randomized trial. Andrology. 2015 Sep;3(5):864-7. doi: 10.1111/andr.12086. Epub 2015 Jul 31. |
| D052801 |
| Male Urogenital Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |