DNA Fragmentation - Effect on Pregnancy Rate
Primary Purpose
Infertility, Male
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Punalpin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Male
Eligibility Criteria
Inclusion Criteria:
- Male fertility patients with increased amount of DNA fragmentation in their spermatozoa
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Punalpin
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Sperm DNA fragmentation
Reduction in DNA fragmentation
Secondary Outcome Measures
Full Information
NCT ID
NCT05397314
First Posted
October 15, 2019
Last Updated
May 25, 2022
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05397314
Brief Title
DNA Fragmentation - Effect on Pregnancy Rate
Official Title
DNA Fragmentation - Effect on Pregnancy Rate
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
January 9, 2021 (Actual)
Study Completion Date
April 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
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
The purpose of this study is to determine whether Punalpin, an antioxidant, has a positive impact on DNA fragmentation in spermatozoa in male fertility patients with increased amount of DNA fragmentation in their spermatozoa. Secondary purpose is to investigate whether there is any positive effect on the subsequent pregnancy rates from the fertility treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Punalpin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Punalpin
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Sperm DNA fragmentation
Description
Reduction in DNA fragmentation
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male fertility patients with increased amount of DNA fragmentation in their spermatozoa
Exclusion Criteria:
-
12. IPD Sharing Statement
Learn more about this trial
DNA Fragmentation - Effect on Pregnancy Rate
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