Clinical trial NCT03319654: Impact of DNA Fragmentation in Sperm on Pregnancy Outcome After Intra-uterine Insemination in a Spontaneous Cycle
Official title: Impact of DNA Fragmentation in Sperm on Pregnancy Outcome After Intra-uterine Insemination in a Spontaneous Cycle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility Unexplained
Infertility, Male
DNA Damage
Keywords: Unexplained Infertility
Idiopathic Infertility
DNA damage
DNA fragmentation
Insemination
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2017-10-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single center, university setting, no commercial affiliation
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: DNA Fragmentation as a Predictor of Live Birth Rate
timeFrame: up to 36 months
Secondary outcomes:
measure: % SDF in the Total Fraction After Density Gradient in the Diagnostic Sample (Pre-IUI)
timeFrame: up to 3 months
measure: % SDF in the Vital Fraction After Density Gradient in the Diagnostic Sample (Pre-IUI)
timeFrame: up to 3 months
measure: % SDF in the Total Fraction in the Ejaculate of the IUI- Sample
timeFrame: 36 months
measure: % SDF in the Vital Fraction in the Ejaculate of the IUI- Sample
timeFrame: 36 months
measure: % SDF in the Total Fraction After Density Gradient in the IUI Sample
timeFrame: 36 months
measure: % SDF in the Vital Fraction After Density Gradient in the IUI Sample
timeFrame: 36 months
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Alessa N Sugihara, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sugihara A, Punjabi U, Roelant E, De Neubourg D. Is There a Relationship between Sperm DNA Fragmentation and Intra-Uterine Insemination Outcome in Couples with Unexplained or Mild Male Infertility? Results from the ID-Trial. Life (Basel). 2022 Dec 20;13(1):11. doi: 10.3390/life13010011.