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NCT06858111 · ClinicalTrials.gov registry record · Phase 3
Fertilo In Vitro Research Study and Trial
A Phase 3 study of In Vitro Maturation of Oocytes, sponsored by Gameto.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 11
- Study locations
NCT06858111 is a Phase 3 study of In Vitro Maturation of Oocytes that is actively recruiting participants, run by Gameto. The registered enrollment target is 500 participants. The trial reports 11 study locations across 7 states.
The verdict
NCT06858111, a Phase 3 study of In Vitro Maturation of Oocytes, is actively recruiting participants, sponsored by Gameto.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 11
- Study locations
Study Summary
The goal of this clinical trial is to evaluate the safety and efficacy of using Fertilo for In vitro maturation (IVM) in participants 18-35 years of age. The main question it aims to answer is whether the use of Fertilo is superior to using Medicult IVM for In vitro maturation. Researchers will compare the number of ongoing pregnancies at 12 weeks gestation for participants in each arm. * Arm 1 participants will have all cumulus oocyte complexes (COCs), or eggs surrounded by helper cells, cultured in Fertilo for 30 hours. * Arm 2 participants will have all cumulus oocyte complexes (COCs), or eggs surrounded by helper cells, cultured in Medicult IVM for 30 hours.
Conditions Studied
Interventions
- BIOLOGICAL Fertilo
- DEVICE Medicult IVM
Study Locations (11)
Texas
- Care Fertility - Bedford
- Dallas Fort Worth Fertility Associates - Dallas
- Shady Grove Houston - Webster
Florida
- Florida Fertility Institute - Clearwater
- IVF Florida - Pembroke Pines
North Carolina
- Reach Fertility - Charlotte
- Conceptions Fertility - Raleigh
California
- HRC Fertility - Encino
Maryland
- Shady Grove Fertility - Rockville
New York
- Columbia University Fertility Center - New York
Utah
- Utah Fertility Center - Pleasant Grove
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2025-04-17 |
| Est. Completion | 2028-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06858111
The ClinicalTrials.gov registry entry for NCT06858111 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gameto, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with In Vitro Maturation of Oocytes appearing as the primary indexed condition, and to 2 interventions - of which Fertilo is the first listed.
NCT06858111 reports 11 study locations spanning 7 distinct geographic areas - top geographies include Texas, Florida, North Carolina.
Frequently Asked Questions
What is clinical trial NCT06858111 about?
NCT06858111 is a clinical study titled "Fertilo In Vitro Research Study and Trial". The goal of this clinical trial is to evaluate the safety and efficacy of using Fertilo for In vitro maturation (IVM) in participants 18-35 years of age. The main question it aims to answer is whether the use of Fertilo is superior to using Medicult IVM for In vitro maturation. Researchers will com...
What is the current status of trial NCT06858111?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2025-04-17. Estimated completion is 2028-01.
What conditions does trial NCT06858111 study?
This clinical trial studies the following conditions: In Vitro Maturation of Oocytes.
What interventions are being tested in trial NCT06858111?
The interventions under investigation include: Fertilo (BIOLOGICAL), Medicult IVM (DEVICE).
Who is sponsoring clinical trial NCT06858111?
This trial is sponsored by Gameto, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06858111 being conducted?
This trial has 11 study locations across California, Florida, Maryland, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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