The pAToMiUM Trial: testing a dietary supplement for men aimed at reducing unexplained miscarriage

Phase 1

• Conditions: nexplained miscarriage and how this may relate to the quality of the sperm DNA at conception, with particular emphasis on chromatin structure and DNA fragmentation and whether this may be improved by male dietary supplementation.; MedDRA version: 20.0Level: HLTClassification code 10065877Term: Dietary and nutritional therapiesSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2019-000315-91-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-30
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

>2 Unexplained miscarriages

In order to determine whether a male patient is eligible for the study sperm DNA damage will be assessed by the TUNEL assay from the baseline semen sample they provide. If the patient sample has elevated DNA damage they will be considered eligible from a baseline semen sample perspective.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Couple not naturally conceiving
Couple have a diagnosed cause of repetitive miscarriage
Male partner is a smoker

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified