Sperm SelectionMACSNCT01265329
Methods for Objective Selection of Competent Sperm
A study testing Negative selection in people with Sperm Selection, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
In spite of the achievements and developement of the assisted reproduction techniques in the last years, there is still an elevated percentage of unsuccessful treatments, needing sometimes repeated attempts to reach pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 37 yearsHealthy volunteers can take part
- Conditions the study is for
- Sperm Selection
- What is being tested?
- Negative selection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2010to Dec 2012
- 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 to 37 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- MEN:
- >3million sperm after swimming process
- WOMEN:
- < 37 YEARS OLD
- NO GYNECOLOGICAL ANOMOLIES
- HORMONAL VALUES WITHIN CLINICAL RANGE
Who cannot join
- NONE
Trial locations and contacts
1 site in 1 country.
About this study
In spite of the achievements and developement of the assisted reproduction techniques in the last years, there is still an elevated percentage of unsuccessful treatments, needing sometimes repeated attempts to reach pregnancy.
The molecular physiology of sperm is being better characterized, and some reports have demonstrated the implication of different molecular processes in the pathophysiology of male infertility.
Read more
Recently, different sperm selection methods have been based on these molecular differences, showing a better quality of the sperm population after selection.
The main objective of this research project is to clinically apply these techniques in order to increase the pregnancy rates per cycle in infertile couples attending assisted reproduction treatments.
- Conditions
- Sperm Selection
- Being tested
- Negative selection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative selectionOther
Sperm selection to continue the treatment with healthy sperm
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No sperm selection |
| Annexine V negative | Experimental | Sperm selection with Annexine V protein Receives: Other: Negative selection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestation
Sperm selection and blood sample confirming gestation
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sperm SelectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcos Meseguer, Instituto Valenciano de Infertilidad, IVI VALENCIA
- Investigators
- Nicolas Garrido, PhD, Principal investigator, IVI Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265329
- Sponsor's protocol ID
- 0810-C-051-MM
- Acronym
- MACS
- Status last verified
- Aug 2014
- First submitted
- 8 Oct 2010
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methods for Objective Selection of Competent Sperm
- ClinicalTrials.gov ID
- NCT01265329
- Acronym / sponsor ID
- MACS / 0810-C-051-MM
- Conditions
- Sperm Selection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Dec 2010 (estimated)
- 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.
In spite of the achievements and developement of the assisted reproduction techniques in the last years, there is still an elevated percentage of unsuccessful treatments, needing sometimes repeated attempts to reach pregnancy.
The molecular physiology of sperm is being better characterized, and some reports have demonstrated the implication of different molecular processes in the pathophysiology of male infertility.
Recently, different sperm selection methods have been based on these molecular differences, showing a better quality of the sperm population after selection.
The main objective of this research project is to clinically apply these techniques in order to increase the pregnancy rates per cycle in infertile couples attending assisted reproduction treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No sperm selection |
| Annexine V negative | Experimental | Other: Negative selectionSperm selection with Annexine V protein |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- >3million sperm after swimming process
- < 37 YEARS OLD
- NO GYNECOLOGICAL ANOMOLIES
- HORMONAL VALUES WITHIN CLINICAL RANGE
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 |
|---|---|---|
| Negative selectionSperm selection to continue the treatment with healthy sperm | Other | Annexine V negative |
Primary outcome
Gestation
Time frame: 14 days
Sperm selection and blood sample confirming gestation
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 5 Aug 2014.
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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.
Nicolas Garrido, PhD principal investigator
IVI Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative selection in people with Sperm Selection, run by Instituto Valenciano de Infertilidad, IVI VALENCIA 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 6 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 5 Aug 2014. 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?
Gestation (time frame: 14 days). 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 5 Aug 2014.