DNA Fragmentation - Effect on Pregnancy Rate

Not Applicable

Completed

• Conditions: Infertility, Male
• Interventions: Other: Placebo; Dietary Supplement: Punalpin

• Registration Number: NCT05397314
• Lead Sponsor: Odense University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2019-10-15
• Primary Completion: 2021-01-09
• Study Completion: 2021-04-09
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-25
• Last Update Submitted: 2022-05-25
• Study First Posted: 2022-05-31
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Punalpin	Punalpin	-

Primary Outcome Measures

Name	Time	Method
Sperm DNA fragmentation	4 months	Reduction in DNA fragmentation