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NCT04298255 · ClinicalTrials.gov registry record · NA
Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples
A NA study of Infertility, Male, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT04298255: Recruiting NA study of Infertility, Male, sponsored by Wake Forest University Health Sciences.
NCT04298255 is a NA study of Infertility, Male that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 50 participants, below the 571-participant average among 8 other Infertility, Male trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04298255, a NA study of Infertility, Male, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Egg fertilization comparison between the groups undergoing the procedure with spermatids only vs spermatids and donor sperms.This fertilization process will be recorded by EmbryoScope under supervision of dedicated clinical embryologist.All the process will be followed and documented according to America Society of Reproductive Medicine (ASRM) guidelines. All the process will be followed and documented according to American Society for Reproductive Medicine (ASRM) guidelines.
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 |
What NCT04298255 shows while recruiting
NCT04298255 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 571-participant average among 8 other Infertility, Male trials with a reported enrollment target (91% lower).
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.
NCT04298255 reports a single indexed study location in North Carolina.
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.
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).
Who is sponsoring clinical trial NCT04298255?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Infertility, Male
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04298255's enrollment target sits among peer trials
50 7th of 8 higher than 1 of 8 other Infertility, Male trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infertility, Male trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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