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Procedure

Incubators for Infertility (VILOCITY Trial)

N/A
Recruiting
Led By Thomas Molinaro, MD, MSCE
Research Sponsored by Reproductive Medicine Associates of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal ovarian reserve: Antimullerian Hormone Level (AMH) ≥ 1.2 ng/mL, Antral Follicle Count (AFC) ≥ 8, Follicle Stimulating Hormone (FSH) FSH ≤ 12 international units (IU)/L, Body Mass Index (BMI) <35
Be between 18 and 65 years old
Must not have
Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness <6mm, or persistent endometrial fluid
Communicating hydrosalpinges without a plan for surgical correct prior to frozen embryo transfer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 7 months after discharge to obstetrician
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to determine if using a specific type of incubator can improve the number of embryos that reach the blastocyst stage during in vitro fertilization (IVF) treatment. The study will

Who is the study for?
This trial is for people undergoing IVF treatment due to infertility. Participants will have their mature oocytes collected and randomly assigned to two groups, each using a different type of incubator (benchtop or box) to culture the embryos.
What is being tested?
The study aims to compare benchtop and box incubators in terms of improving the number of embryos reaching blastocyst stage during IVF. It also looks at embryology outcomes, transfer success, and pregnancy rates between the two methods.
What are the potential side effects?
Since this trial involves standard IVF procedures with different types of incubators rather than drugs or invasive treatments, there are no additional side effects beyond those typically associated with IVF.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My fertility tests are normal and my BMI is under 35.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My uterus lining is thinner than usual or I have persistent fluid.
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I have hydrosalpinges and no surgery planned before embryo transfer.
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I need detailed genetic testing for my embryo due to specific genetic concerns.
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I have undergone surgery to collect sperm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 7 months after discharge to obstetrician
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 7 months after discharge to obstetrician for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blastulation Rate per mature oocyte (M2)
Secondary study objectives
Blastocyst Morphology using Modified Gardner Scale
Blastulation Rate per 2PN
Embryologist Questionnaire
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Oocytes allocated to the box incubatorExperimental Treatment1 Intervention
Half of the mature oocytes and subsequent embryos will be cultured in the box incubator
Group II: Oocytes allocated to the benchtop incubatorExperimental Treatment1 Intervention
Half of the mature oocytes and subsequent embryos will be cultured in the benchtop incubator

Find a Location

Who is running the clinical trial?

Reproductive Medicine Associates of New JerseyLead Sponsor
53 Previous Clinical Trials
37,682 Total Patients Enrolled
31 Trials studying Infertility
19,141 Patients Enrolled for Infertility
CooperSurgical Inc.Industry Sponsor
3 Previous Clinical Trials
401 Total Patients Enrolled
Thomas Molinaro, MD, MSCEPrincipal InvestigatorReproductive Medicine Associates of New Jersey
2 Previous Clinical Trials
15,000 Total Patients Enrolled
1 Trials studying Infertility
10,000 Patients Enrolled for Infertility
~89 spots leftby Jun 2025
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