Pilot antioxidant therapy of men in unexplained miscarriage: the pAToMiUM trial

Phase 3

• Conditions: Miscarriage, elevated sperm DNA fragmentation; Pregnancy and Childbirth

• Registration Number: ISRCTN91556363
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-05
• Last Update Posted: 29 August 2022
• Study Completion: 2023-07-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Feasibility outcomes:<br> 1. Proportion of screened men that are eligible for the trial on the basis of their baseline sperm sample<br> 2. Proportion of eligible couples randomised<br> 3. Proportion of potentially eligible men who consent to baseline sperm sample provision<br> 4. Proportion of randomised men that return for their 1 month and 3 month follow-up visits for additional sperm sample provision<br> 5. Men’s compliance to taking the daily nutritional supplement and reasons for stopping taking the trial intervention early<br> 6. Proportion of couples that withdraw from the trial, and the reasons for this<br> 7. Proportion of couple that are lost to follow-up<br>