Human Sperm Markers of Cryodamage Resistance (NCT02535377) | Clinical Trial Compass
CompletedNot Applicable
Human Sperm Markers of Cryodamage Resistance
Spain40 participantsStarted 2015-02-12
Plain-language summary
Sperm freezing has been employed for decades for male fertility preservation in cases of foreseeable or unexpected loss of fertility to guarantee future paternity, and also as a complement of assisted reproduction techniques.
Sperm quality after thawing is highly variable, even among consecutive samples from the same individual, with mean survival rates around 40%. To date, the molecular basis of the adequate resistance or intolerance to freezing/thawing protocols is unknown, and its knowledge can lead to improvement in the selection of the samples to be frozen and also in the adequate supplement of cryopreservation media. Microarray analysis provides a powerful tool to address the molecular explanation beyond this behaviour, yielding results about comparative messenger ribonucleic acid (mRNA)expression under the two different biological conditions: optimal and suboptimal survival.
Then, the aim of the investigators' study is to determine the genomic profile of sperm samples depending on their survival resistance to cryopreservation, to determine genes involved in cryodamage sensitivity.
Who can participate
Age range
18 Years – 35 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:
The criteria used for the inclusion of donors in the sperm bank will be considered:
* males from 18 to 35 years.
* good physical and psychological conditions and no hereditary diseases
* seminal parameters: concentration \> 40 million sperm / ml; percentage of progressive motility\> 50% percentage of normal forms\> 4%.
* For pregnancy rates after artificial insemination, only women\< 40 years without tubal pathologies and artificial insemination indications will be included.
Exclusion Criteria:
All the population not included in the list of inclusion will be excluded.
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
1
Genomic profile of sperm samples depending on their survival resistance to cryopreservation
Timeframe: A year and a half
Trial details
NCT IDNCT02535377
SponsorInstituto Valenciano de Infertilidad, IVI Alicante