DNA Damage and Subfertility in Males - Impact on ART Outcome

Regionshospitalet Viborg, Skive1,350 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,350

Conditions

Infertility

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * First cycle treatment Exclusion Criteria: * TESA/PESA, more than one cycle

Locations (1)

Fertility Clinic, Skive Regional Hospital

Skive, Denmark

RECRUITING

Outcomes

Primary Outcomes

Number of particpants achieving live birth

Birth of a living child after week 23. Registered through self-reported schemes sent to the clinic.

Time frame: week 23-42 of pregnancy

Secondary Outcomes

Number of participants with clinical pregnancy

Measurement of heart beat by ultrasound scan

Time frame: week 7-8 of pregnancy

Number of participants with biochemical pregnancy

Increase in serum hCG levels

Time frame: Day 14-17 of pregnancy

Cumulative live birth rate

Live births originating from one controlled stimulation.

Time frame: 9-24 months after inclusion

Data from ClinicalTrials.gov

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