Back to resultsThe Effect of Embryo Culture Under a Continuous CO2 Setting Versus a Sequential CO2 Setting
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous CO2 Level
Sponsored by
About this trial
This is an interventional other trial for Infertility
Eligibility Criteria
Major Inclusion Criteria for participants:
1. Patients undergoing IVF stimulation cycle with plan for subsequent FET
Major Exclusion Criteria for participants:
- All patients who do not voluntarily give their written consent for participation
- Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
- Use of surgical procedures to obtain sperm
Sites / Locations
- Reproductive Medicine Associates of New Jersey
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Continuous CO2 Level
Sequential CO2 Level
Arm Description
embryos will remain in a single incubator set at a continuousCO2 level
Current standard of care
Outcomes
Primary Outcome Measures
blastulation rate
the number of zygotes that reach the blastocyst stage
Secondary Outcome Measures
Full Information
NCT ID
NCT04693806
First Posted
December 30, 2020
Last Updated
May 2, 2023
Sponsor
Reproductive Medicine Associates of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT04693806
Brief Title
The Effect of Embryo Culture Under a Continuous CO2 Setting Versus a Sequential CO2 Setting
Official Title
The Effect of Embryo Culture Under a Continuous CO2 Setting Versus a Sequential CO2 Setting
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
January 11, 2021 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive Medicine Associates of New Jersey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if embryo culture under a single CO2 setting improves blastocyst formation rate.
Detailed Description
Following enrollment, patients will undergo ovarian stimulation and oocyte retrieval per routine as previously consented to at the clinic. IVF stimulation protocol will be at the discretion of the patient's individual provider, per routine. Intracytoplasmic Sperm Injection (ICSI) will be performed and embryos will be cultured to the blastocyst stage per routine. There are no changes to the embryology care itself, the only difference within the study is the CO2 level within the incubator pending the patient's randomization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous CO2 Level
Arm Type
Experimental
Arm Description
embryos will remain in a single incubator set at a continuousCO2 level
Arm Title
Sequential CO2 Level
Arm Type
No Intervention
Arm Description
Current standard of care
Intervention Type
Other
Intervention Name(s)
Continuous CO2 Level
Intervention Description
Embryos will be cultured in a single, continuous CO2 setting
Primary Outcome Measure Information:
Title
blastulation rate
Description
the number of zygotes that reach the blastocyst stage
Time Frame
approximately one week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Major Inclusion Criteria for participants:
1. Patients undergoing IVF stimulation cycle with plan for subsequent FET
Major Exclusion Criteria for participants:
All patients who do not voluntarily give their written consent for participation
Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
Use of surgical procedures to obtain sperm
Facility Information:
Facility Name
Reproductive Medicine Associates of New Jersey
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Embryo Culture Under a Continuous CO2 Setting Versus a Sequential CO2 Setting
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