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ROSI for Male Infertility (ROSI Trial)

Led By Hooman Sadri, MD, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male partner ≥18
Male diagnosed with non-obstructive Azoospermia
Must not have
Males with obstructive azoospermia
Males with presence an adequate number of elongated spermatids or spermatozoa
Screening 3 weeks
Treatment Varies
Follow Up post pregnancy full term average 39 to 40 weeks
Awards & highlights


This trial is testing if it's possible to use a cell called a round spermatid to create a pregnancy, without using sperm. They will also test the safety of this method and what effects it has on the embryo.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not specified but may include risks associated with IVF-like procedures such as multiple pregnancies, emotional stress, and complications from egg retrieval or embryo transfer.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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

You may be eligible for the trial if you check “No” for criteria below:
I am a male diagnosed with obstructive azoospermia.
My sperm test shows a normal count.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post pregnancy full term average 39 to 40 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and post pregnancy full term average 39 to 40 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fertility rate
Secondary outcome measures
Aneuploidy rate
Blastocyst formation
Chemical Pregnancy with Positive human chorionic gonadotropin (hCG)
+1 more

Trial Design

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for male infertility often involve assisted reproductive technologies (ART) that directly manipulate sperm or spermatids to facilitate fertilization. Intracytoplasmic sperm injection (ICSI) involves injecting a single sperm directly into an egg, which is particularly useful for men with low sperm count or poor sperm motility. Round Spermatid Injection (ROSI) is a similar technique where immature spermatids are injected into oocytes to create embryos, offering hope for men with non-obstructive azoospermia who lack mature sperm. These treatments are crucial as they provide viable options for achieving pregnancy in cases where natural conception is not possible due to severe male infertility factors.
The role of DEFB126 variation in male infertility and medically assisted reproduction technique outcome.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,253 Previous Clinical Trials
1,010,882 Total Patients Enrolled
Carolinas Fertility Institute (CFI)UNKNOWN
Wake Forest Institute for Regenerative Medicine (WFIRM)UNKNOWN

Media Library

Half ROSI-half Sperm Donor Fertilization (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04298255 — N/A
Male Infertility Research Study Groups: ROSI only, Half ROSI-half Sperm Donor Fertilization
Male Infertility Clinical Trial 2023: Half ROSI-half Sperm Donor Fertilization Highlights & Side Effects. Trial Name: NCT04298255 — N/A
Half ROSI-half Sperm Donor Fertilization (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04298255 — N/A
Male Infertility Patient Testimony for trial: Trial Name: NCT04298255 — N/A
~4 spots leftby Dec 2024