Oocyte Survival After Vitrification With Slush Nitrogen Compared With Liquid Nitrogen
1 other identifier
interventional
27
1 country
1
Brief Summary
The purpose of this study is to determine if the use of slush nitrogen results in higher post-thaw survival rates for oocytes compared to conventionally used liquid nitrogen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2020
CompletedStudy Start
First participant enrolled
April 8, 2020
CompletedFirst Posted
Study publicly available on registry
April 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedJanuary 14, 2022
January 1, 2022
1.1 years
April 8, 2020
January 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
oocyte survival rate
number of viable oocytes post warming
within 5 minutes post warming
Secondary Outcomes (3)
fertilization rate
18 hours post injection
blastulation rate
4-6 days after fertilization
euploid rate
1 week after trophectoderm biopsy
Study Arms (2)
Slush nitrogen
ACTIVE COMPARATORoocytes are randomized to undergo vitrification utilizing slush nitrogen
Liquid Nitrogen
ACTIVE COMPARATORoocytes are randomized to undergo vitrification utilizing liquid nitrogen which is the current standard of care
Interventions
oocytes will be vitrified using liquid nitrogen which is currently routine practice
Eligibility Criteria
You may qualify if:
- Age 30 years or younger who meet institutional criteria to be an oocyte donor.
- Patients who agree to donate oocytes for research purposes and agree to the study protocol.
- The subgroup of oocyte donors age 35-38 will not be part of the primary analysis, and therefore will not be required to meet the age criteria listed above. The older group of donors will be chosen as the clinical discretion of the study investigators. No specific ovarian reserve cutoffs will be required, although factors related to ovarian reserve will be taken into consideration.
You may not qualify if:
- Under 18 years old
- All patients who do not voluntarily give their written consent for participation.
- Patients who do not meet standard institutional criteria for oocyte donation.
- A diagnosis of polycystic ovarian syndrome (PCOS).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07920, United States
Related Publications (1)
Hanson BM, Kim JG, Suarez SI, Ackerman BK, Comito CE, Pangasnan R, Seli E, Hong KH, Scott RT Jr. Embryology outcomes after oocyte vitrification with super-cooled slush nitrogen are similar to outcomes with conventional liquid nitrogen: a randomized controlled trial. Fertil Steril. 2022 Jan;117(1):106-114. doi: 10.1016/j.fertnstert.2021.08.043. Epub 2021 Oct 13.
PMID: 34654569DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- embryologist assessing oocyte survival (primary outcome) is blinded
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2020
First Posted
April 13, 2020
Study Start
April 8, 2020
Primary Completion
May 11, 2021
Study Completion
July 1, 2021
Last Updated
January 14, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share