CompletedNot Applicable

Relationship Between Sperm Head Vacuoles and Sperm DNA Alterations in Infertile Men

France200 participantsStarted 2013-12

Plain-language summary

In men presenting sperm alterations, the selection of genetically undamaged spermatozoa need to be improved in order to increase the success of assisted reproduction treatments. The aim of this study is to determine whether the presence of sperm head vacuoles is associated with sperm DNA alterations.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * men * 18 years old or more * affiliated to social security * with isolated teratozoospermia or oligo-astheno-teratozoospermia according to the WHO guidelines (2010): * sperm concentration \< 15 million per ml or sperm number \< 39 million per ejaculate * progressive motility \< 35% * morphologically normal forms \< 50% according to the modified David's classification (Auger et al., 2001 * mobile spermatozoa selected by density gradient centrifugation \> 1 million, in previous spermograms * with normal constitutional karyotypes (46, XY) * signed an informed consent Exclusion Criteria: * with abnormal constitutional karyotypes * with a major alteration of sperm parameters, with mobile spermatozoa selected by density gradient centrifugation \< 1 million * under tutorship or guardianship by court order

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Correlation coefficient between mean vacuole areas in sperm heads (measured by MSOME) and sperm aneuploidy rates for chromosomes X, Y and 18 (evaluated by FISH)

Timeframe: up to 30 months

Trial details

NCT IDNCT02006446

SponsorUniversity Hospital, Rouen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12

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