DNA Fragmentation - Effect on Pregnancy Rate

• Sponsor: Odense University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05397314
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Actual Duration (Months): 63.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Male	Dietary Supplement: Punalpin; Other: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: DNA Fragmentation - Effect on Pregnancy Rate
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Jan 9, 2021
• Actual Study Completion Date: Apr 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Punalpin	Dietary Supplement: Punalpin
Placebo Comparator: Placebo	Other: Placebo

Outcome Measures

Primary Outcome Measures

1. Sperm DNA fragmentation [4 months]

   Reduction in DNA fragmentation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male fertility patients with increased amount of DNA fragmentation in their spermatozoa

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Odense University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jens Fedder, Professor, Odense University Hospital
• ClinicalTrials.gov Identifier: NCT05397314
• Other Study ID Numbers: S-20140212
• First Posted: May 31, 2022
• Last Update Posted: May 31, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infertility; Infertility, Male

Study Results

No Results Posted as of May 31, 2022