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Oocyte Survival After Vitrification With Slush Nitrogen Compared With Liquid Nitrogen

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitrification via slush nitrogen
Vitrification via liquid nitrogen
Sponsored by
Reproductive Medicine Associates of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Infertility

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

Major Inclusion Criteria for oocyte donors:

  1. Age 30 years or younger who meet institutional criteria to be an oocyte donor.
  2. Patients who agree to donate oocytes for research purposes and agree to the study protocol.
  3. 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.

Major Exclusion Criteria for oocyte donors:

  1. Under 18 years old
  2. All patients who do not voluntarily give their written consent for participation.
  3. Patients who do not meet standard institutional criteria for oocyte donation.
  4. A diagnosis of polycystic ovarian syndrome (PCOS).

Sites / Locations

  • Reproductive Medicine Associates of New Jersey

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Slush nitrogen

Liquid Nitrogen

Arm Description

oocytes are randomized to undergo vitrification utilizing slush nitrogen

oocytes are randomized to undergo vitrification utilizing liquid nitrogen which is the current standard of care

Outcomes

Primary Outcome Measures

oocyte survival rate
number of viable oocytes post warming

Secondary Outcome Measures

fertilization rate
number of zygotes post intracytoplasmic sperm injection procedure
blastulation rate
number of zygotes reaching the blastocyst stage of embryo development
euploid rate
number of chromosomally normal embryos

Full Information

First Posted
April 8, 2020
Last Updated
January 13, 2022
Sponsor
Reproductive Medicine Associates of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT04342364
Brief Title
Oocyte Survival After Vitrification With Slush Nitrogen Compared With Liquid Nitrogen
Official Title
Oocyte Survival After Vitrification With Slush Nitrogen Compared With Liquid Nitrogen
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 8, 2020 (Actual)
Primary Completion Date
May 11, 2021 (Actual)
Study Completion Date
July 1, 2021 (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 the use of slush nitrogen results in higher post-thaw survival rates for oocytes compared to conventionally used liquid nitrogen.
Detailed Description
The study is a randomized, controlled trial which seeks to characterize oocyte survival rate following vitrification and subsequent warming with both slush nitrogen and liquid nitrogen. After warming, fertilization and embryology outcomes will be assessed. Oocyte donors and a single donor sperm source will be utilized. Following enrollment, oocyte donors will undergo ovarian stimulation and oocyte retrieval. The mature (MII) oocytes obtained for each patient will then be assigned a number and randomized via block randomization to one of two treatment groups (liquid nitogen or slush nitrogen). Through block randomization, this will create a paired population of oocytes so that half of each patient's oocytes will undergo cryopreservation with liquid nitrogen and half will undergo cryopreservation with slush nitrogen. Timing of hyaluronidase stripping and vitrification will be consistent with current institutional clinical practice for oocytes. Following cryopreservation, oocytes will be warmed and intracytoplasmic sperm injection will be performed and subsequent embryology outcomes tracked.

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
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial in a paired design
Masking
Outcomes Assessor
Masking Description
embryologist assessing oocyte survival (primary outcome) is blinded
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Slush nitrogen
Arm Type
Active Comparator
Arm Description
oocytes are randomized to undergo vitrification utilizing slush nitrogen
Arm Title
Liquid Nitrogen
Arm Type
Active Comparator
Arm Description
oocytes are randomized to undergo vitrification utilizing liquid nitrogen which is the current standard of care
Intervention Type
Other
Intervention Name(s)
Vitrification via slush nitrogen
Intervention Description
oocytes will be vitrified using slush nitrogen
Intervention Type
Other
Intervention Name(s)
Vitrification via liquid nitrogen
Intervention Description
oocytes will be vitrified using liquid nitrogen which is currently routine practice
Primary Outcome Measure Information:
Title
oocyte survival rate
Description
number of viable oocytes post warming
Time Frame
within 5 minutes post warming
Secondary Outcome Measure Information:
Title
fertilization rate
Description
number of zygotes post intracytoplasmic sperm injection procedure
Time Frame
18 hours post injection
Title
blastulation rate
Description
number of zygotes reaching the blastocyst stage of embryo development
Time Frame
4-6 days after fertilization
Title
euploid rate
Description
number of chromosomally normal embryos
Time Frame
1 week after trophectoderm biopsy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Major Inclusion Criteria for oocyte donors: 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. Major Exclusion Criteria for oocyte donors: 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).
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
Citations:
PubMed Identifier
34654569
Citation
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.
Results Reference
derived

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Oocyte Survival After Vitrification With Slush Nitrogen Compared With Liquid Nitrogen

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