NCT04160208

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

4.1 years

First QC Date

November 8, 2019

Last Update Submit

July 5, 2023

Conditions

Infertility

Keywords

male infertilityDNA fragmentation IndexDFI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Number of participants with clinical pregnancy

    week 7-8 of pregnancy

  • Number of participants with biochemical pregnancy

    Day 14-17 of pregnancy

  • Cumulative live birth rate

    9-24 months after inclusion

Study Arms (3)

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.

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Males of couples attending Skive fertility Clinic

You may qualify if:

  • First cycle treatment

You may not qualify if:

  • TESA/PESA, more than one cycle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Clinic, Skive Regional Hospital

Skive, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Semen

MeSH Terms

Conditions

InfertilityInfertility, Male

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, MaleMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2019

First Posted

November 12, 2019

Study Start

October 1, 2019

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)