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Clinical trials of testicular thermal contraception for men | |||||
Authors | Number of volunteers | Testicular heating modes | No. of exposure cycles | No. of unwanted unwanted | Reversibility |
Mieusset, R. et al. | 14 | Tight-fitting underwear with a simple hole +-2°C by body self-heating in the inguinal pouch 15 hours/d, 7d/7, for 6 to 12 months | +-126 | 0 | 100% in 2 to 3 spermatogenesis cycles. |
Mansat, A. et al. | n/c | n/c | 0 | 100% in 2 to 3 spermatogenesis cycles. | |
Mieusset, R. et al. | 19 | +-285 | 0 | 100% in 2 to 3 spermatogenesis cycles. | |
Mieusset, R. et al. | n/c | n/c | 0 | 100% in 2 to 3 spermatogenesis cycles. | |
F. R. Kandeel and Swerdloff R. S. | n/c | Underwear adjusted +-2°C by body self-heating in the inguinal pouch 15 hours/d, 7d/7, for 6 to 12 months | n/c | 0 | 100% in 2 to 3 spermatogenesis cycles. |
Mieusset, R. et al. | 21 | Heating underpants or Remonte couilles toulousain +-2°C by self-heating in the inguinal pouch 15 hours/d, 7j/7, for 6 to 12 months | +-315 | 0 | 100% in 2 to 3 spermatogenesis cycles. |
Shafik A. | 28 | Suspensors: half ball or stitches to plug the canal +-2°C by body self-heating in the inguinal pouch 24/7 for 12 months | 252 | 0 | 100% in 2 to 3 spermatogenesis cycles. |
Shafik A. | 14 | Suspender: polyester sling on the scrotum +-2°C by body self-heating in the inguinal pouch 24/7 for 12 months | 126 | 0 | 100% in 2 to 3 spermatogenesis cycles. |
Mieusset R., Bujan L. | 9 | Fitted undergarment with a single hole & Fitted undergarment reinforced with a ring structure of soft material at the hole. +-2°C by body self-heating in the inguinal pocket 15 hours/d, 7d/7, duration n/c | +-159 | 1 (due to incorrect use of the method) | 100% in 2 to 3 spermatogenesis cycles. Side effect identified and reversible within 2 to 3 spermatogenesis cycles: 10 to 15% reduction in testicular volume, |
Moeloek N. | n/c | Hanger: scrotal polyester sling. +-2°C by body self-heating in inguinal pouch n/c/, during n/c | n/c | 0 | 100% in 2 to 3 spermatogenesis cycles. |
Wang C et al. | 21 | Polyester-lined sports underwear +- 0.8 to 1°C by body self-warming without testicular rise n/c, during n/c | +-936 | 0 the increase in scrotal temperature induced by the polyester-lined sports racks was insufficient to cause significant suppression of spermatogenesis or impairment of sperm function. | 100% in 2 to 3 spermatogenesis cycles. |
Zhu H. et al. | n/c | n/c +-0.8 to 1°C n/c n/c, during n/c | n/c | 0 Gentle testicular heating safely and reversibly suppresses spermatogenesis. In this study, we sought to clarify the underlying molecular mechanism(s) involved in heat-induced suppression of spermatogenesis in the human testis. Reversible suppression of heat-induced spermatogenesis occurred by modulating the expression of proteins related to proliferation, differentiation, apoptosis and cell survival pathways. These differentially expressed proteins proved to be key molecular targets affecting spermatogenesis after heat treatment. | 100% in 2 to 3 spermatogenesis cycles. |
Ahmad G. et al. | 12 | Heating underpants or toulousain ball lift +-2°C by body self-heating in the inguinal pouch 15 hours/d, 7d/7, 4 months | 48 | 0 | 100% adverse effect identified and reversible within 2 to 3 spermatogenesis cycles: altered chromatin integrity |
Abdelhamid MHM, et al. | 5 | Heating underpants or toulousain ball lift +-2°C by body self-heating in the inguinal pouch 15 hours/d, 7d/7, 4 months | 20 | 0 | 100% adverse effect, reversible within 2 to 3 spermatogenesis cycles: Alteration in chromosome number. |
Mieusset, R. et al. | +-400 | Heating underpants or toulousain ball lift +-2°C by body self-heating in the inguinal pouch 15 hours/d, 7j/7, 18 months | +-7200 | Results of multicenter acceptability study in 2021 | Results of multicenter acceptability study in 2021 |
15 clinical studies | More than 122 volunteers (4 studies with unspecified number of volunteers). | +-2°C body self-heating in inguinal pouch 15 hours/d, 7d/7, maximum duration 48 months | Over 1,331 exhibition cycles | 1 unwanted pregnancy due to incorrect use of the method | 100% in 2 to 3 spermatogenesis cycles. Side effect identified and reversible within 2 to 3 spermatogenesis cycles: Testicular volume reduced by 10 to 15%, Side effects identified and reversible within 2 to 3 spermatogenesis cycles: Chromatin integrity altered & Chromosome number altered. |
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