Hypotaurine Supplementation Benefits in Cryopreservation (HYPOTAURINE)

July 3, 2019 updated by: University Hospital, Clermont-Ferrand

Official Title: Hypotaurine Supplementation in Freezing and Preparation Media Improves Human Sperm DeoxyriboNucleic Acid (DNA) and Fertilizing Ability

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective study was performed on surplus semen after a density gradient centrifugation-frozen-thawing cycle. Samples were obtained from men undergoing routine semen analysis at the Center for Reproductive Medicine. Spermatozoa were selected by density gradient centrifugation, washed and frozen using a programmable device. Each step was performed in parallel with (H+ arm) or without (H- arm) 50mM hypotaurine supplementation. After thawing, investigator team compared for both conditions the total and progressive mobility, vitality, integrity of the acrosome, markers of Protein Kinase A (PKA) dependent capacitation intracellular signaling pathway and nuclear quality by measuring chromatin packaging, DNA fragmentation and oxidation and vacuoles presence in the spermatozoa head.

Study Type

Observational

Enrollment (Actual)

33

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Study Population

Men undergoing routine semen analysis at the Center for Reproductive Medicine

Description

Inclusion Criteria:

  • None

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Hypotaurine : antioxidant and osmoregulator

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
chromatin packaging labelled using aniline blue and chromomycin A3
Time Frame: Day 0
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
Time Frame: Day 0
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
Time Frame: Day 0
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)
Time Frame: Day 0
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
vitality using Eosin Nigrosin
Time Frame: Day 0
Comparison after a cycle of freezing-thawing for both conditions, with or without hypotaurine supplementation of vitality using Eosin Nigrosin
Day 0
motility total and progressive
Time Frame: Day 0
Comparison after a cycle of freezing-thawing for both conditions, with or without hypotaurine supplementation of motility total and progressive
Day 0
integrity of the acrosome using Fluorescein IsoThioCyanate-Pisum Sativum Agglutinin (FITC-PSA) labelling
Time Frame: Day 0
Comparison after a cycle of freezing-thawing for both conditions, with or without hypotaurine supplementation of 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
Time Frame: Day 0
Comparison after a cycle of freezing-thawing for both conditions, with or without hypotaurine supplementation of markers of PKA-dependent capacitation intracellular signaling pathway assessing western blot
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Université d'Auvergne, Institut National de la Santéet de la Recherche Médicale
Université d'Auvergne, Centre National de la Recherche Scientifique
University Hospital, Clermont-Ferrand, Hematology laboratory

Investigators

  • Principal Investigator: Florence BRUGNON, MD, PhD, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

June 21, 2019

First Submitted That Met QC Criteria

July 3, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 3, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014 HYPOTAURINE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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