Sperm AntibodiesNCT02267252
Effects of Male-specific Antibodies on Sex Ratio
An observational study of Sperm Antibodies and Sex Ratio, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Investigation of the ability of antibodies from vasectomized men in binding to Y-spermatozoa as a possible explanation of the lower sex ratio observed after microinsemination using epididymal sperm from vasectomized men. Read more about this study
- Who is it for?
- Ages 25 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sperm Antibodies, Sex Ratio
- What is being tested?
- Antibody-sperm binding
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to Jun 2025
- 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 25 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Vasectomized men
Who may be able to join
- Vasectomized men
Who cannot join
- Men who do not understand the study information
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Fertility Clinic, Odense University Hospital
Odense, 5000
Jens Fedder, Professor, +45 268 20 368, fedder@dadlnet.dk
Jens Fedder, Professor
About this study
Investigation of the ability of antibodies from vasectomized men in binding to Y-spermatozoa as a possible explanation of the lower sex ratio observed after microinsemination using epididymal sperm from vasectomized men.
- Conditions
- Sperm Antibodies, Sex Ratio
- Being tested
- Antibody-sperm binding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibody-sperm bindingOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Y/X sperm ratio after exposure to sperm-specific antibodies
Measured: Up to 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sperm AntibodiesStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Fedder, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267252
- Sponsor's protocol ID
- Lab.Reprod.Biol.- Odense.01
- Status last verified
- Nov 2023
- First submitted
- 8 Oct 2014
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Male-specific Antibodies on Sex Ratio
- ClinicalTrials.gov ID
- NCT02267252
- Acronym / sponsor ID
- Lab.Reprod.Biol.- Odense.01
- Conditions
- Sperm Antibodies, Sex Ratio
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 17 Oct 2014 (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.
Investigation of the ability of antibodies from vasectomized men in binding to Y-spermatozoa as a possible explanation of the lower sex ratio observed after microinsemination using epididymal sperm from vasectomized men.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Vasectomized men
Key inclusion criteria (1 listed)
- Vasectomized men
Key exclusion criteria (1 listed)
- Men who do not understand the study information
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 |
|---|---|---|
| Antibody-sperm binding | Other | – |
Primary outcome
Y/X sperm ratio after exposure to sperm-specific antibodies
Time frame: Up to 28 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
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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.
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 Sperm Antibodies and Sex Ratio, run by Odense University Hospital at 1 site in Denmark.
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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens Fedder, MD, PhD (+45 26820368, fedder@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Y/X sperm ratio after exposure to sperm-specific antibodies (time frame: Up to 28 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 2 Nov 2023.