Clomiphene Citrate in Infertile Men With Idiopathic Oligoasthenozoospermia

Summary

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: * Does drug clomiphene citrate change sperm count and motility in infertile men with idiopathic oligoasthenozoospermia? * What medical problems do participants have when taking drug clomiphene citrate? Researchers will compare drug clomiphene citrate to a placebo (a look-alike substance that contains no drug) to see if drug clomiphene citrate works to treat idiopathic oligoasthenozoospermia.

Timeline

Start

2022-07-01

Primary completion

2023-06-30

Completion

2023-12-31

Publications

• 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.
• 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.
• Background Cocuzza M, Agarwal A. Nonsurgical treatment of male infertility: specific and empiric therapy. Biologics. 2007 Sep;1(3):259-69.
• 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.
• 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.
• 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.
• Results 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.

Drugs

Indications