MedTrace Logo

Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples

NCT04298255 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-09-16

No results posted yet for this study

Summary

The purpose of this research study is to evaluate if special types of cells called round spermatids can be gathered from men with non-obstructive azoospermia and used (in absence of elongated spermatids and spermatozoa) to reliably and effectively create pregnancy with a procedure called Round Spermatid Injection (ROSI). This process is similar to In Vitro Fertilization, or 'IVF'. In addition, this study wants to test the safety of ROSI and see what effects (good and bad) it has on embryo created from this method.

Conditions

  • Infertility, Male

Interventions

OTHER

Round Spermatid Injection (ROSI)

In Vitro Fertilization using Round Spermatid Injection (ROSI)

OTHER

Half ROSI-half Sperm Donor Fertilization

Half ROSI-half Sperm Donor Fertilization

Sponsors & Collaborators

  • Carolinas Fertility Institute (CFI)

    collaborator UNKNOWN

  • Wake Forest Institute for Regenerative Medicine (WFIRM)

    collaborator UNKNOWN

  • Wake Forest Department of Urology

    collaborator UNKNOWN

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Hooman Sadri, MD, PhD · Wake Forest Institute for Regenerative Medicine (WFIRM)

  • Hooman Sadri, MD, PhD · Wake Forest University Health Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-24
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04298255 on ClinicalTrials.gov