Hypotaurine Supplementation Benefits in Cryopreservation
HYPOTAURINE
Official Title: Hypotaurine Supplementation in Freezing and Preparation Media Improves Human Sperm DeoxyriboNucleic Acid (DNA) and Fertilizing Ability
1 other identifier
observational
33
0 countries
N/A
Brief Summary
Although it is widely used, slow freezing can induce strong functional and nuclear spermatic alterations reducing the chances of pregnancy. The study objective is to determinate the effects of the combination of hypotaurine supplementation and spermatozoa selection by Density Gradient Centrifugation (DGC) on human sperm functions and DNA quality during a freezing-thawing cycle.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2014
Longer than P75 for all trials
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
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedFirst Submitted
Initial submission to the registry
June 21, 2019
CompletedFirst Posted
Study publicly available on registry
July 9, 2019
CompletedJuly 9, 2019
June 1, 2019
4.3 years
June 21, 2019
July 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
chromatin packaging labelled using aniline blue and chromomycin A3
Comparison after a cycle of freezing-thawing for both conditions, with or without hypotaurine supplementation of chromatin packaging labelled using aniline blue and chromomycin A3
Day 0
DNA fragmentation using TUNEL assay
Comparison after a cycle of freezing-thawing for both conditions, with or without hypotaurine supplementation of DNA fragmentation using TUNEL assay
Day 0
DNA oxidation assessed by 8-OHdG immunodetections
Comparison after a cycle of freezing-thawing for both conditions, with or without hypotaurine supplementation of DNA oxidation assessed by 8-OHdG immunodetections
Day 0
vacuoles presence in the spermatozoa head using Motile Sperm Organelle Morphology Examination (MSOME)
Comparison after a cycle of freezing-thawing for both conditions, with or without hypotaurine supplementation of vacuoles presence in the spermatozoa head using Motile Sperm Organelle Morphology Examination (MSOME)
Day 0
Secondary Outcomes (4)
vitality using Eosin Nigrosin
Day 0
motility total and progressive
Day 0
integrity of the acrosome using Fluorescein IsoThioCyanate-Pisum Sativum Agglutinin (FITC-PSA) labelling
Day 0
markers of PKA-dependent capacitation intracellular signaling pathway assessing western blot
Day 0
Study Arms (2)
Control arm, "H-"
semen treated without hypotaurine supplementation in density gradient centrifugation, washing and cryopreservation media
Experimental arm, "H+"
semen treated with a 50mM hypotaurine supplementation in density gradient centrifugation, washing and cryopreservation media
Interventions
Hypotaurine has protective effects on sperm motility, capacitation and acrosome reaction and reduces apoptotic markers. Hypotaurine (50mM) was added in density gradient centrifugation, washing and cryopreservation media washing and cryopreservation media before spermatozoa freezing
Eligibility Criteria
Men undergoing routine semen analysis at the Center for Reproductive Medicine
You may qualify if:
- None
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Pons-Rejraji H, Vorilhon S, Difrane A, Dollet S, Bourgne C, Berger M, Chaput L, Pereira B, Bouche C, Drevet JR, Brugnon F. Beneficial effects of hypotaurine supplementation in preparation and freezing media on human sperm cryo-capacitation and DNA quality. Basic Clin Androl. 2021 Nov 4;31(1):26. doi: 10.1186/s12610-021-00144-6.
PMID: 34732137DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Florence BRUGNON, MD, PhD
University Hospital, Clermont-Ferrand
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2019
First Posted
July 9, 2019
Study Start
May 1, 2014
Primary Completion
August 1, 2018
Study Completion
May 1, 2019
Last Updated
July 9, 2019
Record last verified: 2019-06