Using round spermatids to help infertile couples conceive

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research evaluates the effectiveness of Round Spermatid Injection (ROSI) in treating male infertility caused by non-obstructive azoospermia. The study focuses on gathering round spermatids from men who lack elongated spermatids or spermatozoa and using them to fertilize oocytes, similar to In Vitro Fertilization (IVF). It aims to improve the selection process of round spermatids and assess the safety and outcomes of pregnancies achieved through this method. The study is conducted at the Carolinas Fertility Institute in Winston-Salem, North Carolina.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Hooman Sadri, MD, PhD — Wake Forest Institute for Regenerative Medicine (WFIRM)
• Study coordinator: Karla M Oliver
• Email: kaoliver@wakehealth.edu
• Phone: 336-713-3123

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.