Back to resultsEmbryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitrification via slush nitrogen
Sponsored by
About this trial
This is an interventional other trial for Infertility
Eligibility Criteria
Major Inclusion Criteria for participants:
- Patients undergoing IVF stimulation cycle with plan for subsequent frozen embryo transfer (FET)
- Patients electing preimplantation genetic testing for aneuploidy (PGT-A)
- Couples electing single embryo transfer (SET)
Major Exclusion Criteria for participants:
- All patients who do not voluntarily give their written consent for participation
- Under 18 years old, above 42 years old
- BMI > 35
- Maximum day 3 Follicle stimulating hormone (FSH) level of 12 or higher
- Anti-mullerian hormone (AMH) level less than 1.0 g/mL, tested within previous year
- Total basal antral follicle count less than 6 follicles
- Failed more than one previous FET cycle
- Use of oocyte donation
- Use of gestational carrier
- Presence of hydrosalpinges that communicate with endometrial cavity
- Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
- Uncorrected uterine factor infertility (uterine anomaly, submucosal myomas, uterine septum)
- Single gene disorder chromosomal rearrangement requiring a more detailed embryonic genetic analysis
- Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
- Use of surgical procedures to obtain sperm
- Couples undergoing IVF for fertility preservation with no immediate plan for subsequent FET (embryo banking)
- Sex selection
- Personal history of repeated pregnancy loss (two or more unexplained clinical losses defined by presence of fetal heartbeat)
Sites / Locations
- Reproductive Medicine Assoicates of New Jersey
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Vitrification via slush nitrogen
Vitrification via liquid nitrogen
Arm Description
Blastocyst stage embryos will be vitrified via slush nitrogen
Blastocyst stage embryos will be vitrified via conventional liquid nitrogen. This is the current standard of care.
Outcomes
Primary Outcome Measures
sustained implantation rate
fetal heart beat present upon discharge at 8 weeks
Secondary Outcome Measures
clinical pregnancy rate
presence of gestational sac in uterus
miscarriage rate
pregnancy loss
live birth rate
delivery of live infant
Full Information
NCT ID
NCT04496284
First Posted
July 28, 2020
Last Updated
May 2, 2023
Sponsor
Reproductive Medicine Associates of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT04496284
Brief Title
Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
Official Title
Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 5, 2020 (Actual)
Primary Completion Date
May 3, 2022 (Actual)
Study Completion Date
December 20, 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 proposed study is a single-blind randomized controlled trial which seeks to characterize implantation rates following embryo vitrification and subsequent warming with both slush nitrogen and liquid nitrogen. After warming, implantation rates and pregnancy outcomes will be assessed.
Detailed Description
The purpose of this study is to determine if slush nitrogen for embryo vitrification results in higher sustained implantation rates compared to the conventional use of liquid nitrogen. Routine ovarian stimulation, oocyte retrieval and embryology care will ensue. All blastocyst stage embryos will be randomized to either the control (liquid nitrogen) or intervention group (slush nitrogen) and vitrified after trophectoderm biopsy has been performed for PGT-A (preimplantation genetic testing for aneuploidy). A single, chromosomally normal embryo will be transferred in a subsequent frozen embryo transfer cycle per routine. Implantation rates and pregnancy outcomes will be assessed.
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
253 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitrification via slush nitrogen
Arm Type
Experimental
Arm Description
Blastocyst stage embryos will be vitrified via slush nitrogen
Arm Title
Vitrification via liquid nitrogen
Arm Type
No Intervention
Arm Description
Blastocyst stage embryos will be vitrified via conventional liquid nitrogen. This is the current standard of care.
Intervention Type
Other
Intervention Name(s)
Vitrification via slush nitrogen
Intervention Description
blastocyst stage embryos will be vitrified via slush nitrogen
Primary Outcome Measure Information:
Title
sustained implantation rate
Description
fetal heart beat present upon discharge at 8 weeks
Time Frame
approximately 8 weeks gestation age
Secondary Outcome Measure Information:
Title
clinical pregnancy rate
Description
presence of gestational sac in uterus
Time Frame
usually by 5 weeks gestational age
Title
miscarriage rate
Description
pregnancy loss
Time Frame
1-8 months dependent on gestational age of loss
Title
live birth rate
Description
delivery of live infant
Time Frame
9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Major Inclusion Criteria for participants:
Patients undergoing IVF stimulation cycle with plan for subsequent frozen embryo transfer (FET)
Patients electing preimplantation genetic testing for aneuploidy (PGT-A)
Couples electing single embryo transfer (SET)
Major Exclusion Criteria for participants:
All patients who do not voluntarily give their written consent for participation
Under 18 years old, above 42 years old
BMI > 35
Maximum day 3 Follicle stimulating hormone (FSH) level of 12 or higher
Anti-mullerian hormone (AMH) level less than 1.0 g/mL, tested within previous year
Total basal antral follicle count less than 6 follicles
Failed more than one previous FET cycle
Use of oocyte donation
Use of gestational carrier
Presence of hydrosalpinges that communicate with endometrial cavity
Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
Uncorrected uterine factor infertility (uterine anomaly, submucosal myomas, uterine septum)
Single gene disorder chromosomal rearrangement requiring a more detailed embryonic genetic analysis
Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
Use of surgical procedures to obtain sperm
Couples undergoing IVF for fertility preservation with no immediate plan for subsequent FET (embryo banking)
Sex selection
Personal history of repeated pregnancy loss (two or more unexplained clinical losses defined by presence of fetal heartbeat)
Facility Information:
Facility Name
Reproductive Medicine Assoicates 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
Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
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