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

Not Applicable

Completed

Conditions: DNA Damage
Infertility Unexplained
Infertility, Male

Interventions: Diagnostic Test: DNA fragmentation by TUNEL assay

Registration Number: NCT03319654

Lead Sponsor: University Hospital, Antwerp

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spontaneous cycle IUI	DNA fragmentation by TUNEL assay	DNA fragmentation by TUNEL assay DNA fragmentation will be measured both at the time of the diagnostic work-up as at the time of insemination.

Primary Outcome Measures

Name	Time	Method
DNA Fragmentation as a Predictor of Live Birth Rate	up to 36 months	The odds ratio on live birth per unit increase in % total Sperm DNA Fragmentation of the diagnostic sample.

Secondary Outcome Measures

Name	Time	Method
% SDF in the Total Fraction After Density Gradient in the Diagnostic Sample (Pre-IUI)	up to 3 months	% of spermatozoa with DNA fragmentation in the total fraction after density gradient in the diagnostic sample (pre-IUI)
% SDF in the Vital Fraction After Density Gradient in the Diagnostic Sample (Pre-IUI)	up to 3 months	% of spermatozoa with DNA fragmentation in the vital fraction after density gradient in the diagnostic sample (pre-IUI)
% SDF in the Total Fraction in the Ejaculate of the IUI- Sample	36 months	% of spermatozoa with DNA fragmentation in the total fraction in the ejaculate (before density gradient) of the IUI-sample
% SDF in the Vital Fraction in the Ejaculate of the IUI- Sample	36 months	% of spermatozoa with DNA fragmentation in the vital fraction in the ejaculate (before density gradient) of the IUI-sample
% SDF in the Total Fraction After Density Gradient in the IUI Sample	36 months	% of spermatozoa with DNA fragmentation in the total fraction after density gradient in the IUI sample
% SDF in the Vital Fraction After Density Gradient in the IUI Sample	36 months	% of spermatozoa with DNA fragmentation in the vital fraction after density gradient in the IUI sample