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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 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.

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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.

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

FieldValue
Enrollment Target 50 participants
Start Date 2020-08-24
Est. Completion 2026-07
Phase NA

Sponsor

Wake Forest University Health Sciences

1,140 total trials

What the Registry Record Tells You About NCT04298255

The ClinicalTrials.gov registry entry for NCT04298255 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 571-participant average among 8 other Infertility, Male trials with a reported enrollment target (91% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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