Experimental Round Spermatid Injection (ROSI) for Male Infertility
This study is exploring a treatment for couples experiencing male infertility due to a condition called non-obstructive azoospermia (absence of sperm in ejaculate). It investigates whether special cells called round spermatids, found in men who lack mature sperm, can be used to create a pregnancy through a procedure called Round Spermatid Injection (ROSI). This process is similar to In Vitro Fertilization (IVF). The study aims to see how effectively ROSI leads to fertilization and to understand its safety and effects on the resulting embryos. You might be able to join if you are a male partner with non-obstructive azoospermia who has round spermatids but no mature sperm, and your female partner is between 18 and 38 years old or has an AMH (Anti-Mullerian Hormone) level greater than 2 ng/ml. The study is currently unclear on its recruitment status.
- Study design
- This is an interventional study planning to enroll 50 male participants. It compares two approaches: Round Spermatid Injection (ROSI) and a combination of Half ROSI-half Sperm Donor Fertilization.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Fertility rate will be measured at Day 1 after round spermatid injection.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples
At a glance
Conditions
NCT04298255
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Carolinas Fertility Institute (CFI)
Winston-Salem, North Carolinano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Hooman Sadri, MD, PhD · PRINCIPAL_INVESTIGATOR · Wake Forest Institute for Regenerative Medicine (WFIRM)
- Hooman Sadri, MD, PhD · STUDY_DIRECTOR · Wake Forest University Health Sciences
Who to contact
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Inclusion
Exclusion
What this trial measures
- Fertility rateDay 1 after round spermatid injection
Egg fertilization comparison between the groups undergoing the procedure with spermatids only vs spermatids and donor sperms.This fertilization process will be recorded by EmbryoScope under supervision of dedicated clinical embryologist.All the process will be followed and documented according to America Society of Reproductive Medicine (ASRM) guidelines. All the process will be followed and documented according to American Society for Reproductive Medicine (ASRM) guidelines.