DNA Damage and Subfertility in Males - Impact on ART Outcome

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04160208

Acronym

ReproDNA

Enrollment

1350

Registered

2019-11-12

Start date

2019-10-01

Completion date

2023-11-01

Last updated

2023-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

male infertility, DNA fragmentation Index, DFI

Brief 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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* First cycle treatment

Exclusion criteria

* TESA/PESA, more than one cycle

Design outcomes

Primary

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

Secondary

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

Countries

Denmark

Outcome results