DNA Damage and Subfertility in Males - Impact on ART Outcome (ReproDNA)

July 5, 2023 updated by: Peter Humaidan, Regionshospitalet Viborg, Skive

DNA Damage and Subfertility in Males - Impact on Assisted Reproductive Treatment Outcome

A obvational prospective cohort study of men undergoing IUI, IVF and ICSI treatment in Denmark. The aim is to asses the impact of sperm DNA damage, measured as DNA fragmentation index (DFI), on reproductive outcomes after assisted reproductive technology (ART).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1350

Contacts and Locations

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Males of couples attending Skive fertility Clinic

Description

Inclusion Criteria:

  • First cycle treatment

Exclusion Criteria:

  • TESA/PESA, more than one cycle

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
IUI - Insemination
Males of couples undergoing their first IUI treatment
IVF - In vitro fertilisation
Males of couples undergoing their first IVF treatment. Including males of couples who have had previous IUI treatments.
ICSI - Micro Insemination
Males of couples undergoing their first ICSI treatment. Including males of couples who have had previous IUI treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of particpants achieving live birth
Time Frame: week 23-42 of pregnancy
Birth of a living child after week 23. Registered through self-reported schemes sent to the clinic.
week 23-42 of pregnancy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with clinical pregnancy
Time Frame: week 7-8 of pregnancy
Measurement of heart beat by ultrasound scan
week 7-8 of pregnancy
Number of participants with biochemical pregnancy
Time Frame: Day 14-17 of pregnancy
Increase in serum hCG levels
Day 14-17 of pregnancy
Cumulative live birth rate
Time Frame: 9-24 months after inclusion
Live births originating from one controlled stimulation.
9-24 months after inclusion

Collaborators and Investigators

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

Sponsor

Regionshospitalet Viborg, Skive

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)

October 1, 2019

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

November 8, 2019

First Submitted That Met QC Criteria

November 8, 2019

First Posted (Actual)

November 12, 2019

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFI2019Skivecohort

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

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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