UnknownNot Applicable

Selection of Non Apoptotic Human Sperm for in Vitro Fertilization by Using Magnetic Activated Cell Sorting (MACS)

30 participantsStarted 2019-09-01

Plain-language summary

This clinical study has been organised to help improve the embryo quality in couples having high rate of sperm showing apoptotic signs. For this, the investigators intend to use a procedure (MACS: magnetic-activated cell sorting) that allows the identification and the removal of the apoptotic sperm cells. This procedure will increase the chance of using non-apoptotic sperm during in vitro fertilization via Intracytoplasmic Sperm Injection (ICSI). By using this procedure the investigators aim to increase the rate of embryos with good quality for these particular couples.

Who can participate

Age range

18 Years – 43 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.

10.2 Inclusion Criteria * Patients with poor embryo quality in the previous cycles: * Cycles with no embryo transfer due to insufficient embryo quality * "Freeze all" cycles without cryopreservation * Cycles with transfer of embryos with fair and/or poor quality * Previous diagnostic semen analysis with minimum 30% DNA fragmentation * ICSI cycles with fresh ejaculated semen with ≥1 mil spermatozoa after DGC. * Minimum 6 mature oocytes after oocyte pick up. 10.3 Exclusion Criteria * Cycles with frozen semen sample * Cycles with testicular sample * In vitro fertilization (IVF) cycles * Cycles with pre-implantation genetic diagnosis * In vitro maturation cycles

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

utilization rate

Timeframe: 2 years

Trial details

NCT IDNCT03988361

SponsorUniversitair Ziekenhuis Brussel

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-10-01

Contact for this trial

Ileana Mateizel, PhD

003224749119 ileana.mateizel@uzbrussel.be

View on ClinicalTrials.gov More Infertility, Male trials