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Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples
NCT04298255 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- OTHER Round Spermatid Injection (ROSI)
- OTHER Half ROSI-half Sperm Donor Fertilization
Study Locations (1)
North Carolina
- Carolinas Fertility Institute (CFI) — Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-08-24 |
| Est. Completion | 2026-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04298255
The ClinicalTrials.gov registry entry for NCT04298255 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,061 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Infertility, Male appearing as the primary indexed condition, and to 2 interventions — of which Round Spermatid Injection (ROSI) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04298255 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04298255 about?
NCT04298255 is a clinical study titled "Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples". 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 Sperm...
What is the current status of trial NCT04298255?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2020-08-24. Estimated completion is 2026-07.
What conditions does trial NCT04298255 study?
This clinical trial studies the following conditions: Infertility, Male. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04298255?
The interventions under investigation include: Round Spermatid Injection (ROSI) (OTHER), Half ROSI-half Sperm Donor Fertilization (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04298255?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,061 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04298255 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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