Skip to main content
OpenTrials
Completed

NCT Number: NCT04011813

Hypotaurine Supplementation Benefits in Cryopreservation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cryopreservation Human Spermatozoa Parameters Hypotaurine Supplementation Spermatozoa DNA Alterations

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • None

Exclusion criteria

  • None

Treatment and study plan

Hypotaurine : antioxidant and osmoregulator

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

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

Registry information

Official study title

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

Acronym: HYPOTAURINE

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Jul 9, 2019
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.