Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
North Carolina
Carolinas Fertility Institute (CFI)
RECRUITING
Winston-salem
Contact Information
Primary
Karla M Oliver
kaoliver@wakehealth.edu
336-713-3123
Time Frame
Start Date: 2020-08-24
Estimated Completion Date: 2026-07
Participants
Target number of participants: 50
Treatments
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
Authors
Cihan Halicigil
Related Therapeutic Areas
Sponsors
Collaborators: Wake Forest Department of Urology, Wake Forest Institute for Regenerative Medicine (WFIRM), Carolinas Fertility Institute (CFI)
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov