RECRUITING

Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples

Quick Facts

Study Start:2020-08-24
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04298255

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males with no elongated spermatids or spermatozoa present but with round spermatids present on TESE (Testicular Sperm Extraction)
  2. * Male diagnosed with non-obstructive Azoospermia
  3. * Male partner ≥18
  4. * 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.
  1. * Males with obstructive azoospermia
  2. * Males with presence an adequate number of elongated spermatids or spermatozoa

Contacts and Locations

Study Contact

Karla M Oliver
CONTACT
336-713-3123
kaoliver@wakehealth.edu

Principal Investigator

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 Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-24
Study Completion Date2024-12

Study Record Updates

Study Start Date2020-08-24
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • IVF
  • Fertility

Additional Relevant MeSH Terms

  • Infertility, Male