Safety Evaluation of the HyperSperm Sperm Preparation Procedure for In Vitro Fertilization (NCT07478549) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety Evaluation of the HyperSperm Sperm Preparation Procedure for In Vitro Fertilization
Argentina202 participantsStarted 2026-12
Plain-language summary
Prospective, multicenter, randomized clinical study evaluating the safety of a novel sperm preparation method for in vitro fertilization (IVF), compared to standard sperm preparation procedures.
Who can participate
Age range
20 Years – 45 Years
Sex
ALL
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:
General
* Couples undergoing in vitro fertilization (IVF) treatment.
* Planned use of fresh sperm samples obtained by masturbation.
Female
* Age between 20 and 42 years.
* Antral follicle count ≥ 4.
* Eligible for ovarian stimulation and embryo transfer.
Male
* Age between 20 and 45 years.
* Fresh semen sample (not cryopreserved).
* Pre-processing sperm concentration ≥ 5 × 10⁶ sperm/mL.
Exclusion Criteria:
General
* Active sexually transmitted infection (STI).
* Use of donor sperm.
* Medical conditions contraindicating pregnancy or the IVF procedure.
Female
* Uterine anomalies associated with distortion of the uterine cavity.
* Absence of one ovary or functional disorders preventing ovulation.
* Diabetes mellitus or other metabolic disorders.
* Recurrent pregnancy loss, defined as more than two clinical pregnancies without live birth.
Male
\- Any medical condition affecting semen quality that, in the investigator's opinion, may interfere with study participation.
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
Euploidy Rate
Timeframe: From embryo biopsy and PGT analysis up to completion of genetic results, within the IVF cycle (approximately 5-7 days post-fertilization).