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Completed

NCT Number: NCT03319654

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Antwerpen

Edegem, Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DNA fragmentation by TUNEL assay

Diagnostic Test

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

Primary outcomes

  1. DNA Fragmentation as a Predictor of Live Birth Rate

    Time frame: up to 36 months

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

Secondary outcomes

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

    Time frame: up to 3 months

    % of spermatozoa with DNA fragmentation in the total fraction after density gradient in the diagnostic sample (pre-IUI)

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

    Time frame: up to 3 months

    % of spermatozoa with DNA fragmentation in the vital fraction after density gradient in the diagnostic sample (pre-IUI)

  3. % SDF in the Total Fraction in the Ejaculate of the IUI- Sample

    Time frame: 36 months

    % of spermatozoa with DNA fragmentation in the total fraction in the ejaculate (before density gradient) of the IUI-sample

  4. % SDF in the Vital Fraction in the Ejaculate of the IUI- Sample

    Time frame: 36 months

    % of spermatozoa with DNA fragmentation in the vital fraction in the ejaculate (before density gradient) of the IUI-sample

  5. % SDF in the Total Fraction After Density Gradient in the IUI Sample

    Time frame: 36 months

    % of spermatozoa with DNA fragmentation in the total fraction after density gradient in the IUI sample

  6. % SDF in the Vital Fraction After Density Gradient in the IUI Sample

    Time frame: 36 months

    % of spermatozoa with DNA fragmentation in the vital fraction after density gradient in the IUI sample

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Universiteit Antwerpen

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 24, 2017
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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