NCT04011813

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

100
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
Last Updated

July 9, 2019

Status Verified

June 1, 2019

Enrollment Period

4.3 years

First QC Date

June 21, 2019

Last Update Submit

July 3, 2019

Conditions

Keywords

cryopreservationdensity gradient centrifugationDNA fragmentation, oxidation, chromatin packagingantioxidant hypotaurine supplementationcryo-capacitationhuman spermatozoa fertilizing ability

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

Other: Hypotaurine : antioxidant and osmoregulator

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

Experimental arm, "H+"

Eligibility Criteria

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

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.

Study Officials

  • Florence BRUGNON, MD, PhD

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

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