The pAToMiUM trial - pilot Antioxidant Therapy of Men in Unexplained Miscarriage

niversity of Birmingham0 个研究点目标入组 15 人开始时间: 2019年9月5日最近更新: 2022年8月29日

适应症

试验速览

暂无简介。

•Male participants:
•1. Aged 18 or over
•2. Two or more previous unexplained miscarriages with their current female partner
•3. Currently trying to conceive with their current female partner
•4. Willing to provide repeated ejaculated sperm samples for analysis
•5. Sperm DNA damage greater than or equal to 20% at baseline (as determined using the Birmingham TUNEL assay)
•Female participants:
•1. Aged 18 to 40
•2. Willing to take folic acid supplement as per medical guidelines, this is not part of the trial and would be expected in routine practice for all patients

•Male participants:
•1. Previous participation in pAToMiUM
•2. Current smoker
•3. Unwilling to provide repeated ejaculated sperm samples for analysis
•4. Evidence for bacterial infection in semen on baseline semen analysis
•5. Currently taking dietary supplementation and unwilling to switch to the trial supplement alone
•6. Known genetic cause of previous miscarriage (e.g. chromosomal translocation)
•Female participants:
•1. Participation in any other trial of an investigational medicinal product
•2. Female partner is known to be pregnant at the time of randomisation
•3. Known genetic cause of previous miscarriage (e.g. chromosomal translocation)

发起方