Unexplained 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: 20.0 Level: HLT Classification code 10065877 Term: Dietary and nutritional therapies System Organ Class: 100000004865
Conditions
Interventions
Product Name: Menevit
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Vitamin E
CAS Number: 7695-91-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
University of Birmingham
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria: Couple not naturally conceiving Couple have a diagnosed cause of repetitive miscarriage Male partner is a smoker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal question in this research is to study the feasibility, compliance and tolerance of recruiting the male partner, in couples with recurrent unexplained pregnancy loss, to a trial of dietary supplementation. The overarching aim our research is to improve sperm DNA quality in men of couples that have suffered recurrent, unexplained pregnancy loss. This will be achieved using a dietary supplement of minerals and antioxidants given to the men, which we hypothesise should improve sperm DNA quality, this in turn may result in a reduction in the number of miscarriages and thus an increase in successful live births. ;Secondary Objective: Secondary questions relate to the subsequent trial should the pilot be successful, but we would be interested to observe changes in a number of observed measures that we could examine in a later trial. These include sperm parameters; ongoing clinical pregnancy at 12 weeks and other details related to the couple's baseline health.;Primary end point(s): The success of the feasibility study will be assessed by criteria related to the feasibility measurements to ascertain if a larger study is feasible in its current format, needs modification or is unfeasible, and includes recruitment, adherence, follow-up and withdrawal measures. Feasibility outcomes Proportion of screened men that are eligible for the trial on the basis of their baseline sperm sample Proportion of eligible couples randomised Proportion of potentially eligible men who consent to baseline sperm sample provision Proportion of randomised men that return for their 1 month and 3 month follow-up visits for additional sperm sample provision Men’s compliance to taking the daily nutritional supplement and reasons for stopping taking the trial intervention early Proportion of couples that withdraw from the trial, and the reasons for this Proportion of couple that are lost to follow-up ;Timepoint(s) of evaluation of this end point: 3 months post-r | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mechanistic monitoring Amount of sperm DNA damage relative to baseline after 1 month on the trial intervention Changes in conventional sperm parameters after 1 month on the trial intervention Amount of sperm DNA damage relative to baseline after 3 months on the trial intervention Changes in conventional sperm parameters after 3 months on the trial intervention Clinical monitoring Ongoing pregnancy at 12 completed weeks of gestation Spontaneous conception rates whilst man is taking the treatment Adverse events related to the trial intervention Acceptability and impact on patients (outcome) All men will be requested to complete a short questionnaire at their 3 month follow-up visit to assess: How the trial impacted on their day-to-day life, including the attendance of follow-up visits. The acceptability of taking the daily nutritional supplement. Suggestions for making improvements to the recruitment processes.;Timepoint(s) of evaluation of this end point: 12 completed weeks of gestation for those couples that achieve pregnancy. | — |
Countries
United Kingdom
Contacts
Public ContactKirkman-Brown
University of Birmingham
Outcome results
None listed