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

Primary Purpose

Infertility Unexplained, Infertility, Male, DNA Damage

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
DNA fragmentation by TUNEL assay
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility Unexplained focused on measuring Unexplained Infertility, Idiopathic Infertility, DNA damage, DNA fragmentation, Insemination

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitair Ziekenhuis Antwerpen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spontaneous cycle IUI

Arm Description

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.

Outcomes

Primary Outcome Measures

DNA fragmentation as a predictor of clinical pregnancy and live birth rate
DNA fragmentation as evaluated by TUNEL assay.

Secondary Outcome Measures

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
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
DNA fragmentation in relation to the cumulative clinical pregnancy and cumulative live birth rate
DNA fragmentation as evaluated by TUNEL assay.

Full Information

First Posted
September 15, 2017
Last Updated
August 31, 2021
Sponsor
University Hospital, Antwerp
Collaborators
Universiteit Antwerpen
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1. Study Identification

Unique Protocol Identification Number
NCT03319654
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 5, 2017 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp
Collaborators
Universiteit Antwerpen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility Unexplained, Infertility, Male, DNA Damage
Keywords
Unexplained Infertility, Idiopathic Infertility, DNA damage, DNA fragmentation, Insemination

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single center, university setting, no commercial affiliation
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spontaneous cycle IUI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
DNA fragmentation by TUNEL assay
Intervention Description
Direct DNA fragmentation testing with terminal deoxyuridine nick end labeling (TUNEL) assay.
Primary Outcome Measure Information:
Title
DNA fragmentation as a predictor of clinical pregnancy and live birth rate
Description
DNA fragmentation as evaluated by TUNEL assay.
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
DNA fragmentation in the total and vital fraction before and after density gradient in the diagnostic sample (pre-IUI)
Description
DNA fragmentation as evaluated by TUNEL assay
Time Frame
up to 36 months
Title
DNA fragmentation in the total and vital fraction before and after density gradient in the therapeutic sample (IUI sample)
Description
DNA fragmentation as evaluated by TUNEL assay
Time Frame
up to 36 months
Title
DNA fragmentation in relation to the cumulative clinical pregnancy and cumulative live birth rate
Description
DNA fragmentation as evaluated by TUNEL assay.
Time Frame
up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessa N Sugihara, MD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

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

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