Placebo influence on such objective indicators, as sperm quality and infertility, has not been studied previously, but some studies report that placebo may distort even objective outcomes. The aim of current study is to assess the placebo effect on fertility in patients suffering from sperm abnormalities and/or infertility.
We conducted a search of two databases (Scopus and MEDLINE) and identified placebo-controlled clinical trials which focused on sperm abnormalities and/or male infertility treatment. Primary outcomes included changes in semen parameters (volume, total count, sperm concentration in semen, progressive motility, morphology (normal cells)). Secondary outcomes included DNA fragmentation and change in pregnancy rate.
Seventy-seven articles published from 1983 to 2022 were included. Statistically significant changes were observed for the following values: total sperm count, mean change 0.16 (95% CI 0.05, 0.26); P=0.004, I2=75.1%; and progressive motility, mean change 0.13 (95% CI 0.02, 0.24); P=0.026, I2=84.9%. In contrast, placebo did not affect sperm concentration, sperm volume, sperm morphology or DNA fragmentation index. The publication bias for all the values measured with Egger's test and funnel plots was low.
The current meta-analysis indicated a statistically significant increase of total sperm count and progressive motility in the placebo group. In contrast, placebo did not affect sperm concentration, sperm volume, sperm morphology and DNA fragmentation index. These findings should be considered while planning or analyzing placebo-controlled clinical trials.
Minerva urology and nephrology. 2024 Aug [Epub]
Elvira Utigalieva, Andrey Morozov, Ohad Shoshany, Aleksandr Suvorov, Mark Taratkin, Celeste Manfredi, Marco Falcone, Evgeny Bezrukov, Harun Fajkovic, Giorgio I Russo, Dmitry Enikeev, EAU-YAU Sexual and Reproductive Health Working Group
Institute for Clinical Medicine, Sechenov University, Moscow, Russia., Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia., Urology Section, Beilinson Hospital, Rabin Medical Center, Petah Tiqva, Israel., Digital Biodesign and Personalized Healthcare World-Class Research Center, Sechenov University, Moscow, Russia., Department of Woman, Child and General and Specialized Surgery, Luigi Vanvitelli University of Campania, Naples, Italy., Section of Urology U, Molinette Hospital, Turin, Italy., Department of Urology, Medical University of Vienna, Vienna, Austria., University of Catania, Catania, Italy., Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia - .