Using round spermatids to help infertile couples conceive
Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples
NA · Wake Forest University Health Sciences · NCT04298255
This study is testing a new way to help couples with male infertility by using special cells called round spermatids to see if they can successfully fertilize eggs and lead to pregnancy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Wake Forest University Health Sciences (other) |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT04298255 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include males diagnosed with non-obstructive azoospermia who have undergone Testicular Sperm Extraction and have round spermatids present.
Not a fit: Patients with obstructive azoospermia or those who have an adequate number of elongated spermatids or spermatozoa will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new option for men with non-obstructive azoospermia to achieve pregnancy without resorting to sperm donation or adoption.
How similar studies have performed: Previous studies have shown some success with ROSI, but this specific approach is novel and aims to improve upon existing methods.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Winston-Salem, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infertility, Male, IVF, Fertility