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NCT04160208 Clinical Trial

DNA Damage and Subfertility in Males - Impact on ART Outcome

Infertility Clinical Trial

— ReproDNA  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04160208
Other study ID # DFI2019Skivecohort
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date November 1, 2023

Study information
Verified date July 2023
Source Regionshospitalet Viborg, Skive
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 1350
Est. completion date November 1, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - First cycle treatment Exclusion Criteria: - TESA/PESA, more than one cycle

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Fertility Clinic, Skive Regional Hospital Skive

Sponsors (1)
Lead Sponsor Collaborator
Regionshospitalet Viborg, Skive

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of particpants achieving live birth Birth of a living child after week 23. Registered through self-reported schemes sent to the clinic. week 23-42 of pregnancy
Secondary Number of participants with clinical pregnancy Measurement of heart beat by ultrasound scan week 7-8 of pregnancy
Secondary Number of participants with biochemical pregnancy Increase in serum hCG levels Day 14-17 of pregnancy
Secondary Cumulative live birth rate Live births originating from one controlled stimulation. 9-24 months after inclusion
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