Recruiting

ROSI

Sponsor:

Wake Forest University Health Sciences

Code:

NCT04298255

Conditions

Infertility, Male

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Round Spermatid Injection (ROSI)

Half ROSI-half Sperm Donor Fertilization

Study Details

Brief 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

Study ID

NCT04298255

Start date

Aug 24, 2020

Status verified date

Sep, 2025

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Males with no elongated spermatids or spermatozoa present but with round spermatids present on TESE (Testicular Sperm Extraction)
  • Male diagnosed with non-obstructive Azoospermia
  • Male partner ≥18
  • Female partner greater than 18 years of age and less than 38 years of age or Anti Mullerian Hormone (AMH) greater than 2 ng/ml.

Exclusion Criteria:

  • Males with obstructive azoospermia
  • Males with presence an adequate number of elongated spermatids or spermatozoa

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ROSI only

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

experimental: Half ROSI-half Sperm Donor Fertilization

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

Interventions

Round Spermatid Injection (ROSI)

In Vitro Fertilization using Round Spermatid Injection (ROSI)

Half ROSI-half Sperm Donor Fertilization

Half ROSI-half Sperm Donor Fertilization

Primary outcome measure

  • Fertility rate [ Time Frame: Day 1 after round spermatid injection ]

Central Contacts and Locations

Central contacts

Karla M Oliver

336-713-3123kaoliver@wakehealth.edu

Locations

Carolinas Fertility Institute (CFI)

Recruiting

Winston-Salem, North Carolina, United States, 27103

Principal Investigator:

Tamer Yalcinkaya, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 28, 2026

Last verified

Sep, 2025

Keywords

  • IVF
  • Fertility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-28.