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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03319654
Other study ID # UZA TBM -DNA IUI 2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 5, 2017
Est. completion date June 30, 2021

Study information

Verified date August 2021
Source University Hospital, Antwerp
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date June 30, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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), azoƶ- or necrozoospermia

Study Design


Intervention

Diagnostic Test:
DNA fragmentation by TUNEL assay
Direct DNA fragmentation testing with terminal deoxyuridine nick end labeling (TUNEL) assay.

Locations

Country Name City State
Belgium Universitair Ziekenhuis Antwerpen Edegem Antwerp

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Antwerp Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary DNA fragmentation as a predictor of clinical pregnancy and live birth rate DNA fragmentation as evaluated by TUNEL assay. up to 36 months
Secondary DNA fragmentation in the total and vital fraction before and after density gradient in the diagnostic sample (pre-IUI) DNA fragmentation as evaluated by TUNEL assay up to 36 months
Secondary DNA fragmentation in the total and vital fraction before and after density gradient in the therapeutic sample (IUI sample) DNA fragmentation as evaluated by TUNEL assay up to 36 months
Secondary DNA fragmentation in relation to the cumulative clinical pregnancy and cumulative live birth rate DNA fragmentation as evaluated by TUNEL assay. up to 36 months
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