Male InfertilityNCT04849156
Spermatozoa Morphology Selection by Thermotaxis
An observational study of Male Infertility, run by Instituto Valenciano de Infertilidade de Lisboa at 1 site in Portugal.
Trial summary
This study aims to eventually assess the usefulness of thermotaxis for sperm selection in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men only
- Conditions the study is for
- Male Infertility
- What is being tested?
- Sperm selection by thermotaxis
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- 12 Apr 2021to 9 Mar 2022
- 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 to 39 years
- Men only
- Adult
Study population: 10 male sperm donors.
Who may be able to join
- Age: ≥18 and <40 years old.
- Spermatozoa concentration >15 x 10⁶ /mL in all sperm analysis performed in the last 24 months.
- Spermatozoa mobility >32% in all sperm analysis performed in the last 24 months.
- Spermatozoa morphology >4% in all sperm analysis performed in the last 24 months.
- Signed and dated informed consent
Who cannot join
- Use of antibiotics, intravenous illicit drugs, chemotherapy or radiotherapy usage in the last 3 months.
- Active smoking (during the preceding 12 months).
- More than 3 days prior to the last ejaculation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sperm Selection by Thermotaxis: a Novel Technique to Enhance Assisted Reproductive Technologies' Outcomes
This study aims to eventually assess the usefulness of thermotaxis for sperm selection in routine clinical practice.
Read the detailed description
As the world's total fertility rate decline, every year more couples require assisted reproductive technologies (ART) in order to achieve their desire to become parents. However, these techniques are not guaranteed solutions and still many couples with unexplained infertility fail to conceive. One of the reasons might be the relative selection of spermatozoa for the following ART. To minimize a poor selection made by the operator and to standardize spermatozoa selection, we suggest a new method might be used in combination with the routine spermatozoa selection techniques.
Thermotaxis might be used in the ART setting as a tool to select the best spermatozoa as human spermatozoa after capacitation responds positively to a temperature gradient change. Moreover, this might be the possible navigation mechanism of spermatozoa in the female genital tract. We hypothesize that spermatozoa selected by thermotaxis behavior might increase the morphologically normal spermatozoa number in the cohort used during ART.
The aim of this study is to evaluate if thermotaxis is a good method for selecting morphologically normal sperm for ART.
- Conditions
- Male Infertility
- Being tested
- Sperm selection by thermotaxis
- Keywords
- Spermatozoa selection, Thermotaxis, Testicular and sperm biology
- Medical subject headings
- Infertility, Male, Taxis Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperm selection by thermotaxisOther
Selection of healthy sperm by thermotaxis procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of normal spermatozoa morphology
Analysis of sperm samples following thermotaxis (intervention) versus the controls (without thermotaxis).
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start12 Apr 2021
- Primary completion5 Jan 2022
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidade de Lisboa
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Kadir Guleresi, Master, Principal investigator, Instituto Valenciano de Infertilidade de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849156
- Sponsor's protocol ID
- 1902-LIS-028-SR
- Status last verified
- Aug 2022
- First submitted
- 13 Apr 2021
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sperm Selection by Thermotaxis: a Novel Technique to Enhance Assisted Reproductive Technologies' Outcomes
- ClinicalTrials.gov ID
- NCT04849156
- Acronym / sponsor ID
- 1902-LIS-028-SR
- Conditions
- Male Infertility
- Keywords
- Spermatozoa selection, Thermotaxis, Testicular and sperm biology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidade de LisboaResearch network
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 19 Apr 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.
This study aims to eventually assess the usefulness of thermotaxis for sperm selection in routine clinical practice.
Detailed description
As the world's total fertility rate decline, every year more couples require assisted reproductive technologies (ART) in order to achieve their desire to become parents. However, these techniques are not guaranteed solutions and still many couples with unexplained infertility fail to conceive. One of the reasons might be the relative selection of spermatozoa for the following ART. To minimize a poor selection made by the operator and to standardize spermatozoa selection, we suggest a new method might be used in combination with the routine spermatozoa selection techniques.
Thermotaxis might be used in the ART setting as a tool to select the best spermatozoa as human spermatozoa after capacitation responds positively to a temperature gradient change. Moreover, this might be the possible navigation mechanism of spermatozoa in the female genital tract. We hypothesize that spermatozoa selected by thermotaxis behavior might increase the morphologically normal spermatozoa number in the cohort used during ART.
The aim of this study is to evaluate if thermotaxis is a good method for selecting morphologically normal sperm for ART.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- 10 male sperm donors.
Key inclusion criteria (5 listed)
- Age: ≥18 and <40 years old.
- Spermatozoa concentration >15 x 10⁶ /mL in all sperm analysis performed in the last 24 months.
- Spermatozoa mobility >32% in all sperm analysis performed in the last 24 months.
- Spermatozoa morphology >4% in all sperm analysis performed in the last 24 months.
- Signed and dated informed consent
Key exclusion criteria (3 listed)
- Use of antibiotics, intravenous illicit drugs, chemotherapy or radiotherapy usage in the last 3 months.
- Active smoking (during the preceding 12 months).
- More than 3 days prior to the last ejaculation.
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 |
|---|---|---|
| Sperm selection by thermotaxisSelection of healthy sperm by thermotaxis procedure | Other | – |
Primary outcome
Percentage of normal spermatozoa morphology
Time frame: 11 months
Analysis of sperm samples following thermotaxis (intervention) versus the controls (without thermotaxis).
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 4 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Kadir Guleresi, Master principal investigator
Instituto Valenciano de Infertilidade de Lisboa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Infertility, run by Instituto Valenciano de Infertilidade de Lisboa at 1 site in Portugal.
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 3 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 4 Aug 2022. 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 Portugal. 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?
Percentage of normal spermatozoa morphology (time frame: 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2022.