CompletedNot Applicable

Reproductive Outcome After Sperm Selection for Intracytoplasmic Sperm Injection (ICSI) Using Zona Pellucida Proteins

Bulgaria368 participantsStarted 2021-12-03

Plain-language summary

The aim of this study is to analyze the effect of a sperm selection method by adhesion to partners' zona pellucida proteins on the assisted reproduction treatment (ART) outcome parameters.

Who can participate

Age range

20 Years – 50 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: * Clinical diagnosis for primary or secondary infertility * Healthy females * Clinical diagnosis for unexplained infertility * Females between 20 and 45 years old. * Males between 20 and 50 years old. * At least 3 retrieved oocytes per follicular puncture with at least 1 oocyte at germinal vesicle (GV) or metaphase I (MI) stage Exclusion Criteria: * Presence of low quality oocytes * Females with endometrial or ovarian infertility factor

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

Fertilisation rate

Timeframe: 24 hours after ICSI

Embryo quality

Timeframe: 2 to 6 days after ICSI

Implantation rate

Timeframe: 14 days after embryo transfer

Clinical pregnancy rate

Timeframe: 6 weeks after embryo transfer

Trial details

NCT IDNCT05161247

SponsorNadezhda Women's Health Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-03

View on ClinicalTrials.gov More Infertility, Male trials

Who can participate

Age range

20 Years – 50 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.