Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples

Description

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 Overview

Study Details

Study overview

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.

Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples

Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples

Condition
Infertility, Male
Intervention / Treatment

-

Contacts and Locations

Winston-Salem

Carolinas Fertility Institute (CFI), Winston-Salem, North Carolina, United States, 27103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

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

Hooman Sadri, MD, PhD, STUDY_DIRECTOR, Wake Forest University Health Sciences

Study Record Dates

2024-12