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RecruitingNCT04298255

Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples

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Trial Parameters

ConditionInfertility, Male
SponsorWake Forest University Health Sciences
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment50
SexMALE
Min Age18 Years
Max AgeN/A
Start Date2020-08-24
Completion2026-07
Interventions
Round Spermatid Injection (ROSI)Half ROSI-half Sperm Donor Fertilization

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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

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