Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment

April 26, 2023 updated by: Peter Humaidan

Evaluation of Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment

The aim of this study is to investigate the extent of double-stranded DNA damage in sperm in men with unexplained infertility.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mette Jensen, Research assistant
  • Phone Number: 78445718
  • Email: mejen8@rm.dk

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Men with unexplanied infertility undergoing fertility treatment

Description

Inclusion Criteria:

  • Unexplained infertile men who will undergo 1st or 2nd IVF treatment
  • Age over 18 years
  • Normal sperm parameters according to WHO criteria
  • IVF treatment

Exclusion Criteria:

- ICSI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infertile male
Men with unexplained infertility
Other: Sperm DNA Fragmentation
Sperm DNA Fragmentation analysis.
Donors (control)
Fertile sperm donors
Other: Sperm DNA Fragmentation
Sperm DNA Fragmentation analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of double-stranded DNA damage in sperm of men with unexplained infertility.
Time Frame: 30-60 minutes
Sperm DNA Fragmentation done with a Comet Assay analysis
30-60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of single-stranded DNA damage in sperm of men with unexplained infertility
Time Frame: 30-60 minutes
Sperm DNA Fragmentation done with a Comet Assay analysis
30-60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter Humaidan

Collaborators

ExamenLab Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2023

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Estimate)

May 5, 2023

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Doublestrand DNA Fragmentation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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