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

NCT03319654 | Completed Results

• 1 other identifier: UZA TBM -DNA IUI 2017
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility Unexplained; Infertility, Male; DNA Damage

Keywords

Unexplained Infertility; Idiopathic Infertility; DNA damage; DNA fragmentation; Insemination

Outcome Measures

Primary Outcomes (1)

• DNA Fragmentation as a Predictor of Live Birth Rate

  The odds ratio on live birth per unit increase in % total Sperm DNA Fragmentation of the diagnostic sample.

  up to 36 months

Secondary Outcomes (6)

• % SDF in the Total Fraction After Density Gradient in the Diagnostic Sample (Pre-IUI)

  up to 3 months

• % SDF in the Vital Fraction After Density Gradient in the Diagnostic Sample (Pre-IUI)

  up to 3 months

• % SDF in the Total Fraction in the Ejaculate of the IUI- Sample

  36 months

• % SDF in the Vital Fraction in the Ejaculate of the IUI- Sample

  36 months

• % SDF in the Total Fraction After Density Gradient in the IUI Sample

  36 months

Study Arms (1)

Spontaneous cycle IUI

EXPERIMENTAL

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.

Diagnostic Test: DNA fragmentation by TUNEL assay

Interventions

DNA fragmentation by TUNEL assay DIAGNOSTIC_TEST

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

Spontaneous cycle IUI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Universiteit Antwerpen: collaborator

Study Sites (1)

Universitair Ziekenhuis Antwerpen

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (1)

• 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.

  PMID: 36675960 BACKGROUND

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Alessa Sugihara
• Organization: Antwerp University Hospital, Belgium

alessa.sugihara@uza.be

00328213684

Study Officials

• Alessa N Sugihara, MD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASugihara

Model Details: Single center, university setting, no commercial affiliation

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: October 24, 2017
• Study Start: October 5, 2017
• Primary Completion: May 31, 2021
• Study Completion: June 30, 2021
• Last Updated: November 15, 2024
• Results First Posted: November 15, 2024

Record last verified: 2024-09

Locations

BE (1)