50 Participants Needed

ROSI for Male Infertility

(ROSI Trial)

JB
SV
HS
TY
KM
Overseen ByKarla M Oliver
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Studies have shown that children born after ROSI do not have any unusual physical, mental, or genetic problems compared to those born naturally. However, more participants and long-term follow-up studies are needed to fully assess the safety of the ROSI technique.12345

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?

HS

Hooman Sadri, MD, PhD

Principal Investigator

Wake Forest Institute for Regenerative Medicine (WFIRM)

HS

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Round Spermatid Injection (ROSI) procedure is performed to fertilize oocytes using round spermatids or a combination of round spermatids and donor sperm

1 week
1 visit (in-person)

Embryo Development and Monitoring

Embryo development is monitored, including blastocyst formation and aneuploidy evaluation

1 week
Daily monitoring (in-person)

Follow-up

Participants are monitored for pregnancy outcomes, including chemical pregnancy and live birth rate

39-40 weeks
Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Half ROSI-half Sperm Donor Fertilization
  • Round Spermatid Injection (ROSI)
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: ROSI onlyExperimental Treatment1 Intervention
Group II: Half ROSI-half Sperm Donor FertilizationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Carolinas Fertility Institute (CFI)

Collaborator

Trials
1
Recruited
50+

Wake Forest Institute for Regenerative Medicine (WFIRM)

Collaborator

Trials
1
Recruited
50+

Wake Forest Department of Urology

Collaborator

Trials
1
Recruited
50+

Published Research Related to This Trial

In a study of 457 men with azoospermia, 342 were diagnosed with non-obstructive azoospermia (NOA), but only 43% had retrievable spermatozoa, indicating that many men may not benefit from round spermatid injections (ROSI).
Among the 194 men with NOA who had no spermatozoa, 75% were diagnosed with Sertoli cell-only syndrome, suggesting that round spermatids suitable for ROSI were rare, highlighting the need to reassess the clinical value of this intervention.
Questioning the utility of round spermatid injections in men with non-obstructive azoospermia.Barda, S., Mano, R., Lehavi, O., et al.[2022]
Round spermatid injection (ROSI) has resulted in the successful birth and development of 14 children from 12 women, demonstrating its potential as a viable option for men with severe infertility issues where traditional sperm retrieval methods fail.
All children born through ROSI have shown no unusual physical, mental, or epigenetic problems, indicating that this method may be safe for producing genetically related offspring in cases where other options are not available.
Fourteen babies born after round spermatid injection into human oocytes.Tanaka, A., Nagayoshi, M., Takemoto, Y., et al.[2018]
Non-obstructive azoospermia (NOA) is a significant cause of male infertility, with many affected men having some active spermatogenesis, which can be utilized in assisted reproductive techniques like round spermatid injection (ROSI).
The ROSI technique, which involves injecting round spermatids from testicular biopsies into oocytes, shows promise but requires more participants and long-term studies to confirm its reliability and improve success rates.
Clinical values and advances in round spermatid injection (ROSI).Tekayev, M., Vuruskan, AK.[2022]

Citations

Questioning the utility of round spermatid injections in men with non-obstructive azoospermia. [2022]
Fourteen babies born after round spermatid injection into human oocytes. [2018]
Clinical values and advances in round spermatid injection (ROSI). [2022]
Round spermatid injection into human oocytes: a systematic review and meta-analysis. [2021]
How to improve the clinical outcome of round spermatid injection (ROSI) into the oocyte: Correction of epigenetic abnormalities. [2023]
Evaluation of the post-implantation development of mouse embryos derived from round spermatid injection. [2023]
Spermatid injection into human oocytes. II. Clinical application in the treatment of infertility due to non-obstructive azoospermia. [2019]
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