NCT05397314

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2021

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

5 years

First QC Date

October 15, 2019

Last Update Submit

May 25, 2022

Conditions

Infertility, Male

Outcome Measures

Primary Outcomes (1)

  • Sperm DNA fragmentation

    Reduction in DNA fragmentation

    4 months

Study Arms (2)

Punalpin

EXPERIMENTAL
Dietary Supplement: Punalpin

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

PunalpinDIETARY_SUPPLEMENT
Punalpin
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 15, 2019

First Posted

May 31, 2022

Study Start

January 1, 2016

Primary Completion

January 9, 2021

Study Completion

April 9, 2021

Last Updated

May 31, 2022

Record last verified: 2022-05