Sperm CapacitationFOSFOTIRNCT04962100
Capacitation-associated Protein Tyrosine Phosphorylation As a Possible Biomarker of Sperm Selection
A study testing Analysis of capacitation-associated tyrosine phosphorylation in human sperm by flow cytometry in people with Sperm Capacitation, run by Vida Recoletas Sevilla at 1 site in Spain.
Trial summary
Sperm undergo complex selection processes and physiological changes as they move through the female reproductive tract. Ejaculated-sperm must undergo a set of molecular and biochemical changes globally named as capacitation in order to acquire the ability to fertilize the oocyte. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sperm Capacitation
- What is being tested?
- Analysis of capacitation-associated tyrosine phosphorylation in human sperm by flow cytometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 1 siteSpain
- Study dates
- 29 Jun 2021to 30 Sep 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To have signed the written informed consent before starting any procedure related to the study.
- Sexual abstinence (2 to 5 days).
- To be a male patient who delivers a fresh seminal sample for diagnosis or artificial insemination treatment.
- To be a male donor who delivers a fresh seminal sample for donation or for previous tests to include him in the donation programme.
- To be a female patient undergoing artificial insemination.
Who cannot join
- Use of sperm of testicular or epididymal origin.
- Cryptozoospermia or oligozoospermia with sperm concentration <1 mill/ml.
- Ejaculates obtained with more than 5 days of sexual abstinence.
- Frozen semen samples for artificial insemination cycles with partner's semen.
- Female patients who present uterine malformations that compromise the viability of the pregnancy (intramural or submucosal fibroids > 3 cm, polyps, adenomyosis or congenital or acquired malformations). Female patients with hydrosalpinx.
- Patients who have suffered two or more previous abortions (repeated abortions).
- Patients with a body mass index greater than 30 Kg / m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Capacitation-associated Protein Tyrosine Phosphorylation As a Possible Biomarker of Sperm Selection in Sperm from Patients and Donors
Sperm undergo complex selection processes and physiological changes as they move through the female reproductive tract. Ejaculated-sperm must undergo a set of molecular and biochemical changes globally named as capacitation in order to acquire the ability to fertilize the oocyte. These changes include post-translational modifications of sperm proteins, with phosphorylation of tyrosine residues being one of the most outstanding characteristics of the capacitation process. In the laboratory, the capacitation process is recreated artificially before performing artificial insemination or in vitro fertilization treatments. The sample is then incubated until it is used in the treatment. Reproductive success rates can be affected by differences in incubation times and levels of capacitation of the sample. In this study, the investigators intend to study the capacitation state of the sample by measuring the levels of phosphorylation of the tyrosine residues of the proteins contained in the sperm that have already been subjected to the capacitation process in vitro.
Read the detailed description
The human male deposits millions of sperm cells in the woman's vagina at the time of ejaculation. However, only a few sperm cells are able to reach the fallopian tubes. In fact, only between 100-1000 sperm will reach the cumulus-oocyte complex and only one will be able to fertilize the oocyte.
The sperm cells from the ejaculate of all mammals are unable to fertilize the oocyte. In order to acquire the fertilization competence, sperm must undergo a process called capacitation. Capacitation has been defined as a complex phenomenon that involves biochemical and physiological changes in the sperm.
These changes are such as:
- Loss of proteins or replacement by others of lower molecular weight
- Transformation of phospholipids, decreased cholesterol/phospholipid ratio
- Changes in the carbohydrate fraction of glycoproteins
- Lipid and protein mobility
Not all the events involved in the complex capacitation process are known.
The following stages can be differentiated:
- Cell membrane fluidification
- Increased intracellular Ca2+
- Generation of controlled amounts of reactive oxygen species
- Increased intracellular pH and hyperpolarization of sperm membrane potential
- Protein phosphorylation (serine, threonine and tyrosine residues)
Under in vivo conditions, motile sperm actively migrate through the cervical mucus and are separated from the rest of the ejaculate. In vitro, sperm capacitation can be achieved if they are subjected to particular culture conditions during the necessary period of time.
After capacitation, sperm acquires three characteristics:
- Hyperactivation.
- Acrosomic reaction.
- Sperm-oocyte interaction.
The capacitation process is necessary for the sperm to be able to cross the layer of cells that surround the oocyte and to undergo the acrosome reaction. Only a fraction of sperm are known to reach the capacitation state at some point.
The capacitation process depends mainly on post-translational modifications of proteins. One of the most important modifications that these proteins undergo is phosphorylation. During sperm capacitation, serine, threonine and tyrosine residues are phosphorylated. However, phosphorylation of tyrosine residues is the best indicator of sperm capacitation.
The evaluation of the phosphorylation of the tyrosine residues of the sperm proteins by flow cytometry makes it possible to assess the degree of capacitation of the sperm in vitro and to determine how many of them have carried out this process adequately . As previously mentioned, not all sperm cells of a sample undergo the capacitation process and not all of them present the same percentage of phosphorylated proteins in tyrosine residues.
Certain events, such as the cryopreservation process and the incubation times of the samples until their use in fertility treatments (IA or IVF / ICSI), can affect the capacitation process. Therefore, the measurement of the levels of tyrosine phosphorylation of the sperm by flow cytometry can allow the investigators to know the level of capacitation of the sample. There are studies that report changes in success rates when samples are incubated different period of times. The incubation period affects the rate of acrosomal reaction of sperm and may even affect DNA fragmentation. Furthermore, the temperature at which such incubation is carried out also seems to affect sperm capacitation.
Based on the above, this project aims to analyze the possible correlation between the levels of tyrosine phosphorylation in sperm and the functional quality of the seminal sample, as well as the reproductive success of the cycle. In parallel, the investigators will analyze whether the sperm capacitation process is affected by the incubation times of the sample once it has been capacitated or whether it depends exclusively on the quality of the seminal sample and is intrinsic to the male.
- Conditions
- Sperm Capacitation
- Being tested
- Analysis of capacitation-associated tyrosine phosphorylation in human sperm by flow cytometry
- Keywords
- Capacitation, Tyrosine phosphorylation, Flow cytometry, Biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of capacitation-associated tyrosine phosphorylation in human sperm by flow cytometryOther
After the assessment of the macroscopic and microscopic characteristics of the sample, we will wash the sample and process it using three layers of density gradients.
In the case of samples for diagnostic analysis, the remaining volume will be incubated in at 37ºC, and 0.1-0.2 ml aliquots will be taken from the end of the processing at t0 (just before introducing the sample in the incubator), at t1 (after one hour of incubation) and at t3 (after 3 hours of incubation). Additionally, a sample will be taken after washing, prior to processing the sample with the density gradients. In the case of samples processed for insemination, an additional aliquot will be taken at the exact moment in which the insemination is carried out and the elapsed incubation time will be noted.
The evaluation of the capacitation will be carried out by analyzing the state of phosphorylation of tyrosines by flow cytometry.
| Study group | Role | What they receive |
|---|---|---|
| Study population | Experimental | Male patients and donors who provide a sample of fresh ejaculated semen will be the population of this study, as well as female patients undergoing artificial insemination with their partner's semen or frozen donor semen. Receives: Other: Analysis of capacitation-associated tyrosine phosphorylation in human sperm by flow cytometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the state of sperm capacitation by assessing the phosphorylation of tyrosine residues
Flow cytometry analysis will be carried out to evaluate the levels of phosphorylation of tyrosine residues in sperm proteins of seminal samples capacitated in vitro in order to determine their capacitation statuscytometry of seminal samples capacitated in vitro in order to determine their capacitation status
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start29 Jun 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Sperm CapacitationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vida Recoletas Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristina González Ravina, PhD, Principal investigator, IVI RMA Sevilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962100
- Sponsor's protocol ID
- 1608-SEV-065-CG
- Acronym
- FOSFOTIR
- Status last verified
- Oct 2024
- First submitted
- 29 Jun 2021
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be available to other researchers.
Publications
Said TM, Land JA. Effects of advanced selection methods on sperm quality and ART outcome: a systematic review. Hum Reprod Update. 2011 Nov-Dec;17(6):719-33. doi: 10.1093/humupd/dmr032. Epub 2011 Aug 25.
PubMed 21873262Aitken RJ, Nixon B. Sperm capacitation: a distant landscape glimpsed but unexplored. Mol Hum Reprod. 2013 Dec;19(12):785-93. doi: 10.1093/molehr/gat067. Epub 2013 Sep 26.
PubMed 24071444Bianchi E, Doe B, Goulding D, Wright GJ. Juno is the egg Izumo receptor and is essential for mammalian fertilization. Nature. 2014 Apr 24;508(7497):483-7. doi: 10.1038/nature13203. Epub 2014 Apr 16.
PubMed 24739963Henkel R. Sperm preparation: state-of-the-art--physiological aspects and application of advanced sperm preparation methods. Asian J Androl. 2012 Mar;14(2):260-9. doi: 10.1038/aja.2011.133. Epub 2011 Dec 5.
PubMed 22138904Visconti PE, Bailey JL, Moore GD, Pan D, Olds-Clarke P, Kopf GS. Capacitation of mouse spermatozoa. I. Correlation between the capacitation state and protein tyrosine phosphorylation. Development. 1995 Apr;121(4):1129-37. doi: 10.1242/dev.121.4.1129.
PubMed 7743926Visconti PE. Understanding the molecular basis of sperm capacitation through kinase design. Proc Natl Acad Sci U S A. 2009 Jan 20;106(3):667-8. doi: 10.1073/pnas.0811895106. Epub 2009 Jan 14. No abstract available.
PubMed 19144927Liu DY, Clarke GN, Baker HW. Tyrosine phosphorylation on capacitated human sperm tail detected by immunofluorescence correlates strongly with sperm-zona pellucida (ZP) binding but not with the ZP-induced acrosome reaction. Hum Reprod. 2006 Apr;21(4):1002-8. doi: 10.1093/humrep/dei435. Epub 2006 Jan 20.
PubMed 16428332Kumaresan A, Siqueira AP, Hossain MS, Johannisson A, Eriksson I, Wallgren M, Bergqvist AS. Quantification of kinetic changes in protein tyrosine phosphorylation and cytosolic Ca(2)(+) concentration in boar spermatozoa during cryopreservation. Reprod Fertil Dev. 2012;24(4):531-42. doi: 10.1071/RD11074.
PubMed 22541541Escoffier J, Navarrete F, Haddad D, Santi CM, Darszon A, Visconti PE. Flow cytometry analysis reveals that only a subpopulation of mouse sperm undergoes hyperpolarization during capacitation. Biol Reprod. 2015 May;92(5):121. doi: 10.1095/biolreprod.114.127266. Epub 2015 Apr 8.
PubMed 25855261Naresh S, Atreja SK. The protein tyrosine phosphorylation during in vitro capacitation and cryopreservation of mammalian spermatozoa. Cryobiology. 2015 Jun;70(3):211-6. doi: 10.1016/j.cryobiol.2015.03.008. Epub 2015 Mar 28.
PubMed 25828199Mansour RT, Serour MG, Abbas AM, Kamal A, Tawab NA, Aboulghar MA, Serour GI. The impact of spermatozoa preincubation time and spontaneous acrosome reaction in intracytoplasmic sperm injection: a controlled randomized study. Fertil Steril. 2008 Sep;90(3):584-91. doi: 10.1016/j.fertnstert.2006.11.176. Epub 2008 Mar 4.
PubMed 18295761Zhang XD, Chen MY, Gao Y, Han W, Liu DY, Huang GN. The effects of different sperm preparation methods and incubation time on the sperm DNA fragmentation. Hum Fertil (Camb). 2011 Sep;14(3):187-91. doi: 10.3109/14647273.2011.604817. Epub 2011 Aug 23.
PubMed 21859363Marin-Briggiler CI, Tezon JG, Miranda PV, Vazquez-Levin MH. Effect of incubating human sperm at room temperature on capacitation-related events. Fertil Steril. 2002 Feb;77(2):252-9. doi: 10.1016/s0015-0282(01)02982-x.
PubMed 11821080
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capacitation-associated Protein Tyrosine Phosphorylation As a Possible Biomarker of Sperm Selection in Sperm from Patients and Donors
- ClinicalTrials.gov ID
- NCT04962100
- Acronym / sponsor ID
- FOSFOTIR / 1608-SEV-065-CG
- Conditions
- Sperm Capacitation
- Keywords
- Capacitation, Tyrosine phosphorylation, Flow cytometry, Biomarker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Vida Recoletas SevillaUniversity, hospital or other
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 14 Jul 2021 (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.
Sperm undergo complex selection processes and physiological changes as they move through the female reproductive tract. Ejaculated-sperm must undergo a set of molecular and biochemical changes globally named as capacitation in order to acquire the ability to fertilize the oocyte. These changes include post-translational modifications of sperm proteins, with phosphorylation of tyrosine residues being one of the most outstanding characteristics of the capacitation process. In the laboratory, the capacitation process is recreated artificially before performing artificial insemination or in vitro fertilization treatments. The sample is then incubated until it is used in the treatment. Reproductive success rates can be affected by differences in incubation times and levels of capacitation of the sample. In this study, the investigators intend to study the capacitation state of the sample by measuring the levels of phosphorylation of the tyrosine residues of the proteins contained in the sperm that have already been subjected to the capacitation process in vitro.
Detailed description
The human male deposits millions of sperm cells in the woman's vagina at the time of ejaculation. However, only a few sperm cells are able to reach the fallopian tubes. In fact, only between 100-1000 sperm will reach the cumulus-oocyte complex and only one will be able to fertilize the oocyte.
The sperm cells from the ejaculate of all mammals are unable to fertilize the oocyte. In order to acquire the fertilization competence, sperm must undergo a process called capacitation. Capacitation has been defined as a complex phenomenon that involves biochemical and physiological changes in the sperm.
These changes are such as:
- Loss of proteins or replacement by others of lower molecular weight
- Transformation of phospholipids, decreased cholesterol/phospholipid ratio
- Changes in the carbohydrate fraction of glycoproteins
- Lipid and protein mobility
Not all the events involved in the complex capacitation process are known.
The following stages can be differentiated:
- Cell membrane fluidification
- Increased intracellular Ca2+
- Generation of controlled amounts of reactive oxygen species
- Increased intracellular pH and hyperpolarization of sperm membrane potential
- Protein phosphorylation (serine, threonine and tyrosine residues)
Under in vivo conditions, motile sperm actively migrate through the cervical mucus and are separated from the rest of the ejaculate. In vitro, sperm capacitation can be achieved if they are subjected to particular culture conditions during the necessary period of time.
After capacitation, sperm acquires three characteristics:
- Hyperactivation.
- Acrosomic reaction.
- Sperm-oocyte interaction.
The capacitation process is necessary for the sperm to be able to cross the layer of cells that surround the oocyte and to undergo the acrosome reaction. Only a fraction of sperm are known to reach the capacitation state at some point.
The capacitation process depends mainly on post-translational modifications of proteins. One of the most important modifications that these proteins undergo is phosphorylation. During sperm capacitation, serine, threonine and tyrosine residues are phosphorylated. However, phosphorylation of tyrosine residues is the best indicator of sperm capacitation.
The evaluation of the phosphorylation of the tyrosine residues of the sperm proteins by flow cytometry makes it possible to assess the degree of capacitation of the sperm in vitro and to determine how many of them have carried out this process adequately . As previously mentioned, not all sperm cells of a sample undergo the capacitation process and not all of them present the same percentage of phosphorylated proteins in tyrosine residues.
Certain events, such as the cryopreservation process and the incubation times of the samples until their use in fertility treatments (IA or IVF / ICSI), can affect the capacitation process. Therefore, the measurement of the levels of tyrosine phosphorylation of the sperm by flow cytometry can allow the investigators to know the level of capacitation of the sample. There are studies that report changes in success rates when samples are incubated different period of times. The incubation period affects the rate of acrosomal reaction of sperm and may even affect DNA fragmentation. Furthermore, the temperature at which such incubation is carried out also seems to affect sperm capacitation.
Based on the above, this project aims to analyze the possible correlation between the levels of tyrosine phosphorylation in sperm and the functional quality of the seminal sample, as well as the reproductive success of the cycle. In parallel, the investigators will analyze whether the sperm capacitation process is affected by the incubation times of the sample once it has been capacitated or whether it depends exclusively on the quality of the seminal sample and is intrinsic to the male.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | Experimental | Other: Analysis of capacitation-associated tyrosine phosphorylation in human sperm by flow cytometryMale patients and donors who provide a sample of fresh ejaculated semen will be the population of this study, as well as female patients undergoing artificial insemination with their partner's semen or frozen donor semen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To have signed the written informed consent before starting any procedure related to the study.
- Sexual abstinence (2 to 5 days).
- To be a male patient who delivers a fresh seminal sample for diagnosis or artificial insemination treatment.
- To be a male donor who delivers a fresh seminal sample for donation or for previous tests to include him in the donation programme.
- To be a female patient undergoing artificial insemination.
Key exclusion criteria (7 listed)
- Use of sperm of testicular or epididymal origin.
- Cryptozoospermia or oligozoospermia with sperm concentration <1 mill/ml.
- Ejaculates obtained with more than 5 days of sexual abstinence.
- Frozen semen samples for artificial insemination cycles with partner's semen.
- Female patients who present uterine malformations that compromise the viability of the pregnancy (intramural or submucosal fibroids > 3 cm, polyps, adenomyosis or congenital or acquired malformations). Female patients with hydrosalpinx.
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 |
|---|---|---|
| Analysis of capacitation-associated tyrosine phosphorylation in human sperm by flow cytometryAfter the assessment of the macroscopic and microscopic characteristics of the sample, we will wash the sample and process it using three layers of density gradients. In the case of samples for diagnostic analysis, the remaining volume will be incubated in at 37ºC, and 0.1-0.2 ml aliquots will be taken from the end of the processing at t0 (just before introducing the sample in the incubator), at t1 (after one hour of incubation) and at t3 (after 3 hours of incubation). Additionally, a sample will be taken after washing, prior to processing the sample with the density gradients. In the case of samples processed for insemination, an additional aliquot will be taken at the exact moment in which the insemination is carried out and the elapsed incubation time will be noted. The evaluation of the capacitation will be carried out by analyzing the state of phosphorylation of tyrosines by flow cytometry. | Other | Study population |
Primary outcome
To determine the state of sperm capacitation by assessing the phosphorylation of tyrosine residues
Time frame: 1 day
Flow cytometry analysis will be carried out to evaluate the levels of phosphorylation of tyrosine residues in sperm proteins of seminal samples capacitated in vitro in order to determine their capacitation statuscytometry of seminal samples capacitated in vitro in order to determine their capacitation status
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 8 Oct 2024.
- Background: PubMed 21873262Said TM, Land JA. Effects of advanced selection methods on sperm quality and ART outcome: a systematic review. Hum Reprod Update. 2011 Nov-Dec;17(6):719-33. doi: 10.1093/humupd/dmr032. Epub 2011 Aug 25.
- Background: PubMed 24071444Aitken RJ, Nixon B. Sperm capacitation: a distant landscape glimpsed but unexplored. Mol Hum Reprod. 2013 Dec;19(12):785-93. doi: 10.1093/molehr/gat067. Epub 2013 Sep 26.
- Background: PubMed 24739963Bianchi E, Doe B, Goulding D, Wright GJ. Juno is the egg Izumo receptor and is essential for mammalian fertilization. Nature. 2014 Apr 24;508(7497):483-7. doi: 10.1038/nature13203. Epub 2014 Apr 16.
- Background: PubMed 22138904Henkel R. Sperm preparation: state-of-the-art--physiological aspects and application of advanced sperm preparation methods. Asian J Androl. 2012 Mar;14(2):260-9. doi: 10.1038/aja.2011.133. Epub 2011 Dec 5.
- Background: PubMed 7743926Visconti PE, Bailey JL, Moore GD, Pan D, Olds-Clarke P, Kopf GS. Capacitation of mouse spermatozoa. I. Correlation between the capacitation state and protein tyrosine phosphorylation. Development. 1995 Apr;121(4):1129-37. doi: 10.1242/dev.121.4.1129.
- Background: PubMed 19144927Visconti PE. Understanding the molecular basis of sperm capacitation through kinase design. Proc Natl Acad Sci U S A. 2009 Jan 20;106(3):667-8. doi: 10.1073/pnas.0811895106. Epub 2009 Jan 14. No abstract available.
- Background: PubMed 16428332Liu DY, Clarke GN, Baker HW. Tyrosine phosphorylation on capacitated human sperm tail detected by immunofluorescence correlates strongly with sperm-zona pellucida (ZP) binding but not with the ZP-induced acrosome reaction. Hum Reprod. 2006 Apr;21(4):1002-8. doi: 10.1093/humrep/dei435. Epub 2006 Jan 20.
- Background: PubMed 22541541Kumaresan A, Siqueira AP, Hossain MS, Johannisson A, Eriksson I, Wallgren M, Bergqvist AS. Quantification of kinetic changes in protein tyrosine phosphorylation and cytosolic Ca(2)(+) concentration in boar spermatozoa during cryopreservation. Reprod Fertil Dev. 2012;24(4):531-42. doi: 10.1071/RD11074.
- Background: PubMed 25855261Escoffier J, Navarrete F, Haddad D, Santi CM, Darszon A, Visconti PE. Flow cytometry analysis reveals that only a subpopulation of mouse sperm undergoes hyperpolarization during capacitation. Biol Reprod. 2015 May;92(5):121. doi: 10.1095/biolreprod.114.127266. Epub 2015 Apr 8.
- Background: PubMed 25828199Naresh S, Atreja SK. The protein tyrosine phosphorylation during in vitro capacitation and cryopreservation of mammalian spermatozoa. Cryobiology. 2015 Jun;70(3):211-6. doi: 10.1016/j.cryobiol.2015.03.008. Epub 2015 Mar 28.
- Background: PubMed 18295761Mansour RT, Serour MG, Abbas AM, Kamal A, Tawab NA, Aboulghar MA, Serour GI. The impact of spermatozoa preincubation time and spontaneous acrosome reaction in intracytoplasmic sperm injection: a controlled randomized study. Fertil Steril. 2008 Sep;90(3):584-91. doi: 10.1016/j.fertnstert.2006.11.176. Epub 2008 Mar 4.
- Background: PubMed 21859363Zhang XD, Chen MY, Gao Y, Han W, Liu DY, Huang GN. The effects of different sperm preparation methods and incubation time on the sperm DNA fragmentation. Hum Fertil (Camb). 2011 Sep;14(3):187-91. doi: 10.3109/14647273.2011.604817. Epub 2011 Aug 23.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be available to other researchers.
Related trials for Sperm Capacitation
RecruitingObservational study
Efficacy and Safety of a New Sperm Capacitation Method
Reproductive Issues, Male Infertility
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.
Cristina González Ravina, PhD principal investigator
IVI RMA Sevilla
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analysis of capacitation-associated tyrosine phosphorylation in human sperm by flow cytometry in people with Sperm Capacitation, run by Vida Recoletas Sevilla at 1 site in Spain.
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 5 inclusion and 7 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 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
To determine the state of sperm capacitation by assessing the phosphorylation of tyrosine residues (time frame: 1 day). 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 NCT04962100, which also lists 13 linked publications.
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 8 Oct 2024.