CryopreservationHYPOTAURINENCT04011813
Hypotaurine Supplementation Benefits in Cryopreservation
An observational study of Cryopreservation and Human Spermatozoa Parameters, run by University Hospital, Clermont-Ferrand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cryopreservation, Human Spermatozoa Parameters, Hypotaurine Supplementation
- What is being tested?
- Hypotaurine : antioxidant and osmoregulator
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2014to 1 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men undergoing routine semen analysis at the Center for Reproductive Medicine
Who may be able to join
- None
Who cannot join
- None
About this study
Official title: 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.
Read the 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.
- Conditions
- Cryopreservation, Human Spermatozoa Parameters, Hypotaurine Supplementation, Spermatozoa DNA Alterations
- Being tested
- Hypotaurine : antioxidant and osmoregulator
- Keywords
- cryopreservation, density gradient centrifugation, DNA fragmentation, oxidation, chromatin packaging, antioxidant hypotaurine supplementation, cryo-capacitation, human spermatozoa fertilizing ability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypotaurine : antioxidant and osmoregulatorOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Hypotaurine : antioxidant and osmoregulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
Measured: Day 0
Secondary outcomes (4)
vitality using Eosin Nigrosin
Comparison after a cycle of freezing-thawing for both conditions, with or without hypotaurine supplementation of vitality using Eosin Nigrosin
Measured: Day 0
motility total and progressive
Comparison after a cycle of freezing-thawing for both conditions, with or without hypotaurine supplementation of motility total and progressive
Measured: Day 0
integrity of the acrosome using Fluorescein IsoThioCyanate-Pisum Sativum Agglutinin (FITC-PSA) labelling
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
Measured: Day 0
markers of PKA-dependent capacitation intracellular signaling pathway assessing western blot
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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 May 2014
- Primary completion1 Aug 2018
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CryopreservationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Florence BRUGNON, MD, PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011813
- Sponsor's protocol ID
- 2014 HYPOTAURINE
- Acronym
- HYPOTAURINE
- Status last verified
- Aug 2026
- First submitted
- 21 Jun 2019
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34732137
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Official Title: Hypotaurine Supplementation in Freezing and Preparation Media Improves Human Sperm DeoxyriboNucleic Acid (DNA) and Fertilizing Ability
- ClinicalTrials.gov ID
- NCT04011813
- Acronym / sponsor ID
- HYPOTAURINE / 2014 HYPOTAURINE
- Conditions
- Cryopreservation, Human Spermatozoa Parameters, Hypotaurine Supplementation, Spermatozoa DNA Alterations
- Keywords
- cryopreservation, density gradient centrifugation, DNA fragmentation, oxidation, chromatin packaging, antioxidant hypotaurine supplementation, cryo-capacitation, human spermatozoa fertilizing ability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- 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
- Study start
- 1 May 2014 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm, "H-" | – | –semen treated without hypotaurine supplementation in density gradient centrifugation, washing and cryopreservation media |
| Experimental arm, "H+" | – | Other: Hypotaurine : antioxidant and osmoregulatorsemen treated with a 50mM hypotaurine supplementation in density gradient centrifugation, washing and cryopreservation media |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men undergoing routine semen analysis at the Center for Reproductive Medicine
Key inclusion criteria (1 listed)
- None
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypotaurine : antioxidant and osmoregulatorHypotaurine 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 | Other | Experimental arm, "H+" |
Primary outcome
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
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
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
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)
4 secondary outcomes
vitality using Eosin Nigrosin
Time frame: Day 0
motility total and progressive
Time frame: Day 0
integrity of the acrosome using Fluorescein IsoThioCyanate-Pisum Sativum Agglutinin (FITC-PSA) labelling
Time frame: Day 0
markers of PKA-dependent capacitation intracellular signaling pathway assessing western blot
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Results publication: PubMed 34732137Pons-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence BRUGNON, MD, PhD principal investigator
University Hospital, Clermont-Ferrand
Questions about this trial
What is this clinical trial studying?
An observational study of Cryopreservation and Human Spermatozoa Parameters, run by University Hospital, Clermont-Ferrand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chromatin packaging labelled using aniline blue and chromomycin A3 (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04011813, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.