ROSI for Male Infertility (ROSI Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByHooman Sadri, MD, PhD

Age: 18+

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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

My male partner is 18 years old or older.

I am a male diagnosed with a condition where I produce no sperm.

My test results show only round spermatids, no mature sperm.

Exclusion Criteria

I am a male diagnosed with obstructive azoospermia.

My sperm test shows a normal count.

Participant Groups

The study tests if injecting round spermatids directly into eggs (ROSI) can lead to pregnancy in cases of severe male infertility. It compares ROSI with using half donor sperm to see which is safer and more effective at creating viable embryos.

2Treatment groups

Experimental Treatment

Group I: ROSI onlyExperimental Treatment1 Intervention

Option 1: injecting extracted round spermatids (less mature form of haploid germ cells than elongated spermatid or spermatozoon) from male partner into the harvested egg of a female partner

Group II: Half ROSI-half Sperm Donor FertilizationExperimental Treatment1 Intervention

Option 2: Harvested eggs from the female partner will be separated in two groups, with one group being fertilized with round spermatids and the other group fertilized with donor sperm