ROSI for Male Infertility
(ROSI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a procedure that uses immature sperm cells to help men who can't produce mature sperm have biological children. The process involves selecting these cells and injecting them into an egg, with extra steps to ensure the egg is ready to develop. This technique has been explored as an alternative for men who cannot produce mature sperm.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is ROSI safe for humans?
How does the treatment Half ROSI-half Sperm Donor Fertilization differ from other treatments for male infertility?
This treatment is unique because it involves injecting round spermatids (immature sperm cells) directly into an egg, which is a novel approach for men with non-obstructive azoospermia (a condition where no sperm is present in the ejaculate). Unlike traditional sperm donation, this method allows men to potentially have their own genetic offspring even when mature sperm are not available.12346
What data supports the effectiveness of the treatment Half ROSI-half Sperm Donor Fertilization, Round Spermatid Injection (ROSI) for male infertility?
Research shows that ROSI has led to the birth of children in cases where men have no mature sperm, but the success rates are much lower compared to using mature sperm. While some children have been born healthy using this method, the overall chances of a successful pregnancy and delivery are relatively low.12347
Who Is on the Research Team?
Hooman Sadri, MD, PhD
Principal Investigator
Wake Forest Institute for Regenerative Medicine (WFIRM)
Hooman Sadri, MD, PhD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
This trial is for couples facing male infertility due to non-obstructive azoospermia, where the man lacks mature sperm in his semen. Men must have round spermatids present and be over 18 years old. Women partners should be between 18-38 years or have an AMH level above 2 ng/ml.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Round Spermatid Injection (ROSI) procedure is performed to fertilize oocytes using round spermatids or a combination of round spermatids and donor sperm
Embryo Development and Monitoring
Embryo development is monitored, including blastocyst formation and aneuploidy evaluation
Follow-up
Participants are monitored for pregnancy outcomes, including chemical pregnancy and live birth rate
What Are the Treatments Tested in This Trial?
Interventions
- Half ROSI-half Sperm Donor Fertilization
- Round Spermatid Injection (ROSI)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
Carolinas Fertility Institute (CFI)
Collaborator
Wake Forest Institute for Regenerative Medicine (WFIRM)
Collaborator
Wake Forest Department of Urology
Collaborator