CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
DNA fragmentation by TUNEL assayother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03319654
NCT03319654N/ACompleted

Impact of DNA Fragmentation in Sperm on Pregnancy Outcome After Intra-uterine Insemination in a Spontaneous Cycle

University Hospital, Antwerp·interventional·Posted Oct 24, 2017·Updated Nov 15, 2024

In Brief

A clinical study evaluating DNA fragmentation by TUNEL assay for Infertility Unexplained and 2 related conditions. Completed, enrolled 120 participants across 1 site.

Detailed Summary

Infertility affects about 10% of all couples and is defined by a failure to achieve a clinical pregnancy within a year of regular unprotected sexual intercourse. Up to one third of these couples will not have an identifiable cause after routine investigation, id est idiopathic infertility. The current diagnosis of male infertility relies on the World Health Organization (WHO) 2010 criteria which focus on concentration, motility and morphology in comparison to cut-off values of a fertile population. Alas, the relevance of the conventional semen analysis for the choice of treatment and the predictive value for an infertile couple with idiopathic or mild male infertility embarking on medically assisted reproduction (MAR) remains questionable. In other words, there is a strong clinical need to distinguish fertile from infertile men through new sperm function testing and to be able to select both the patient population who will benefit from MAR as well as the type of treatment. Numerous studies utilizing different techniques for assessing sperm DNA fragmentation support the existence of a significant association between sperm DNA damage and pregnancy outcomes. In this prospective cohort study the investigators aim to study the role of sperm DNA fragmentation analysis in selecting the patient who will benefit from intra-uterine insemination (IUI) therapy since IUI is still considered the first step in MAR and is performed at a large scale in Belgium and worldwide.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 24, 2017
Enrollment StartOct 5, 2017
Primary CompletionMay 31, 2021
Study CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 8.7 years ago

Interventions

DNA fragmentation by TUNEL assayother

Direct DNA fragmentation testing with terminal deoxyuridine nick end labeling (TUNEL) assay.