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Procedure

ROSI for Male Infertility (ROSI Trial)

N/A
Recruiting
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 partner ≥18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post pregnancy full term average 39 to 40 weeks
Awards & highlights

ROSI Trial Summary

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.

ROSI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My male partner is 18 years old or older.
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My male partner is 18 years old or older.
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I am a male diagnosed with a condition where I produce no sperm.
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My female partner is between 18 and 38 years old or has an AMH level over 2 ng/ml.
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My test results show only round spermatids, no mature sperm.
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I am a male diagnosed with a condition where I produce no sperm.
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My test results show only round spermatids, no mature sperm.

ROSI Trial Timeline

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

ROSI 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

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,235 Previous Clinical Trials
1,001,946 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are contributing to this research trial?

"Affirmative, the information hosted on clinicaltrials.gov reveals that this trial is presently searching for participants. It was initially uploaded to the platform on August 24th 2020 and most recently updated on October 22nd 2022. The study requires 50 patients from one center of care."

Answered by AI

Are patients being recruited for this trial at the present time?

"Indeed, according to clinicaltrials.gov the trial is still looking for participants; it was posted on August 24th 2020 and last modified October 26th 2022. The research necessitates 50 volunteers from a single medical centre."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
Carolinas Fertility Institute (CFI)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I hope this trial will help to get pregnant ❤️. I recently did TESE surgery and they only found round sperm cells with no mature sperm. We were planning on doing IVF but did not happen so I am hoping this procedure will help me get some mature sperm.
PatientReceived 2+ prior treatments
Having a baby is our latest challenge in our couple. We married late and have been trying to get a pregnancy since day 1. My husband has sperm issue even if he is a father of 3 girls. We have had 4 IVFs and are looking for scientific solutions to reach our goal. We hope that you have the solution for us.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

When can we start? What costs do appear? How long do screen visits take? How much are visits and the trials?
PatientReceived 1 prior treatment
It looks like I might not be eligible because I didn't have any sperm found and pathology said sertoli only. Is that true or is there some hope?
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Carolinas Fertility Institute (CFI): < 48 hours
Typically responds via
Email
Average response time
  • < 2 Days
Recent research and studies
~8 spots leftby Dec 2024