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Status unknownNCT05846256Updated May 6, 2023

Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment

An observational study in Infertility, Male, sponsored by Peter Humaidan. Status unknown at 1 site in Denmark. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by Peter Humaidan · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
125
Ages
18 Years and older
Sex
Male
01

Study summary

The aim of this study is to investigate the extent of double-stranded DNA damage in sperm in men with unexplained infertility.

02

Conditions studied

  • Infertility, Male

Keywords

  • Sperm DNA Fragmentation
  • Lifestyle
  • Doublestrand DNA Fragmentatio
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 125 is below the median of 200 across 714 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Peter Humaidan is the lead sponsor of 16 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Men with unexplanied infertility undergoing fertility treatment

Inclusion criteria

  • Unexplained infertile men who will undergo 1st or 2nd IVF treatment
  • Age over 18 years
  • Normal sperm parameters according to WHO criteria
  • IVF treatment

Exclusion criteria

Exclusion Criteria:

  • ICSI
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
125 participants (estimated)
Patient registry
No

Groups and cohorts

  • Infertile male

    Men with unexplained infertility

    Other: Sperm DNA Fragmentation

  • Donors (control)

    Fertile sperm donors

    Other: Sperm DNA Fragmentation

Interventions

  • OtherSperm DNA Fragmentation

    Sperm DNA Fragmentation analysis.

06

What researchers measure

Primary outcomes

  1. The proportion of double-stranded DNA damage in sperm of men with unexplained infertility.

    Sperm DNA Fragmentation done with a Comet Assay analysis

    Time frame: 30-60 minutes

Secondary outcomes

  1. The proportion of single-stranded DNA damage in sperm of men with unexplained infertility

    Sperm DNA Fragmentation done with a Comet Assay analysis

    Time frame: 30-60 minutes

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05846256
Lead sponsor
Peter Humaidan
Collaborators
ExamenLab Ltd
Responsible party
Peter Humaidan (Professor, Consultant, Regionshospitalet Viborg, Skive) — Sponsor-investigator
First posted
May 6, 2023
Start date
Apr 25, 2023
Primary completion
May 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
May 6, 2023

Study contacts

Peter Humaidan, Professor
Contact
peter.humaidan@midt.rm.dk
78445760
Mette Jensen, Research assistant
Contact
mejen8@rm.dk
78445718

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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