NCT04298255 Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples
| NCT ID | NCT04298255 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Infertility, Male |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-08-24 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2020-08-24 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Hooman Sadri, MD, PhD
PRINCIPAL INVESTIGATOR
Wake Forest Institute for Regenerative Medicine (WFIRM)
Frequently Asked Questions
Who can join the NCT04298255 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Infertility, Male. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04298255 currently recruiting?
Yes, NCT04298255 is actively recruiting participants. Contact the research team at kaoliver@wakehealth.edu for enrollment information.
Where is the NCT04298255 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT04298255 clinical trial?
NCT04298255 is sponsored by Wake Forest University Health Sciences. The principal investigator is Hooman Sadri, MD, PhD at Wake Forest Institute for Regenerative Medicine (WFIRM). The trial plans to enroll 50 participants.