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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: Recruiting Phase 3 study of In Vitro Maturation of Oocytes, sponsored by Gameto.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cumulative ongoing pregnancy from cycles initiated within 6 months post-randomization. The primary endpoint of ongoing pregnancy is assessed at 12 weeks gestation or later. Cumulative ongoing pregnancy is determined using the cumulative outcome of up to the first two embryo transfers. Subjects with a detectable fetal heartbeat, considered normal and healthy, are considered as having achieved an ongoing pregnancy. "Normal" will be determined as expected for the gestational age ranging from 110 bp
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 |
What NCT06858111 shows while recruiting
NCT06858111 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
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 lists 11 locations in 7 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06858111's enrollment target sits among peer trials
500 744th of 2000 higher than 1,227 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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