Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04298255
Status
Recruiting
Apply to this trial

Conditions

  • Infertility, Male

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Round Spermatid Injection (ROSI) — OTHER
    In Vitro Fertilization using Round Spermatid Injection (ROSI)
  • Half ROSI-half Sperm Donor Fertilization — OTHER
    Half ROSI-half Sperm Donor Fertilization

Study Details

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.

Key Dates

Start date
Aug 24, 2020
Status verified
Sep 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Carolinas Fertility Institute (CFI)Winston-SalemNorth Carolina27103
Tamer Yalcinkaya, MD (PRINCIPAL_INVESTIGATOR)
Hooman Sadri, MD, PhD (PRINCIPAL_INVESTIGATOR)
Banafsheh Nikmehr, PhD (SUB_INVESTIGATOR)
Anuradha Devineni, MD, MS (SUB_INVESTIGATOR)

Find similar trials in Winston-Salem, NC

By research site
Carolinas Fertility Institute (CFI)· Winston-Salem, NC

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