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N/A N=114 Diagnostic

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

Infertility Unexplained · Infertility, Male · DNA Damage

Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: DNA Fragmentation as a Predictor of Live Birth Rate — 32 Participants — p=0.04

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
DNA fragmentation by TUNEL assay (Diagnostic_test)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University Hospital, Antwerp
Primary completion
May 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
DNA Fragmentation as a Predictor of Live Birth Rate
32 0.04 sig
SECONDARY
% SDF in the Total Fraction After Density Gradient in the Diagnostic Sample (Pre-IUI)
9.6
SECONDARY
% SDF in the Vital Fraction After Density Gradient in the Diagnostic Sample (Pre-IUI)
0.6
SECONDARY
% SDF in the Total Fraction in the Ejaculate of the IUI- Sample
8
SECONDARY
% SDF in the Vital Fraction in the Ejaculate of the IUI- Sample
1
SECONDARY
% SDF in the Total Fraction After Density Gradient in the IUI Sample
8.3
SECONDARY
% SDF in the Vital Fraction After Density Gradient in the IUI Sample
0.4

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.

Eligibility Criteria

Inclusion Criteria

Couples seeking fertility treatment after at least 12 months of unprotected intercourse are eligible. All couples underwent basic fertility investigations which included semen analysis, evaluation of menstrual cycle, and tubal patency testing.

Exclusion Criteria

Double sided tubal disease, severe endometriosis (classified as revised American Society for Reproductive Medicine stage III or IV), premature ovarian failure, and known endocrine disorders (such as Cushing's syndrome or adrenal hyperplasia), azoö- or necrozoospermia

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03319654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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