Prospective, Randomized Trial Comparing ICSI to Insemination for Non-Male Factor Patients Undergo… (NCT05548101) | Clinical Trial Compass
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Prospective, Randomized Trial Comparing ICSI to Insemination for Non-Male Factor Patients Undergoing PGT-A
500 participantsStarted 2022-11-01
Plain-language summary
Intracytoplasmic sperm injection (ICSI) is a procedure performed during in vitro fertilization (IVF) in which a single sperm is injected directly into an oocyte. This procedure was developed for male factor infertility due to its requirement for a very small number of viable sperm. However, its use has expanded and is now recommended for IVF cycles in which preimplantation genetic testing for aneuploidies (PGT-A) is performed on blastocysts. We hypothesize that the ICSI procedure may interfere with the normal meiosis II process that occurs during fertilization, and lead to a higher rate of aneuploid blastocysts. In our study we will randomly assign non-male factor infertility patients to either conventional insemination or ICSI and compare the rate of karyotypically normal embryos in each group.
Who can participate
Age range
18 Years – 39 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:
* Female partner aged 18-39 years old with at least 10 oocytes following retrieval
* Male partner with initial semen analysis with greater than or equal to 16 million sperm/mL, greater than or equal to 42% motile sperm, greater than or equal to 16.4 million total motile sperm, greater than or equal to 30% progressive motility, and greater than or equal to 4% normal morphology (as defined by WHO 6th edition)
Exclusion Criteria:
* Fertilization failure or more than one implantation failure from previous IVF cycles
* Male factor infertility as defined by sperm concentration less than 16 million sperm/mL, motility less than 42%, total motile count less than 16.4 million, progressive motility less than 30%, or normal morphology less than 4%
* Female partner over age 39 years old
* Female partner with 9 or fewer oocytes following retrieval
* Singe gene analysis by preimplantation genetic testing for monogenic disorders (PGT-M) being performed
* ICSI being performed for any reason other than PGT-A
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.