Oocyte Survival After Vitrification With Slush Nitrogen Compared With Liquid Nitrogen

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Reproductive Medicine Associates of New Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Slush nitrogen
oocytes are randomized to undergo vitrification utilizing slush nitrogen
oocytes will be vitrified using slush nitrogen
Active Comparator: Liquid Nitrogen
oocytes are randomized to undergo vitrification utilizing liquid nitrogen which is the current standard of care
oocytes will be vitrified using liquid nitrogen which is currently routine practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oocyte survival rate
Time Frame: within 5 minutes post warming
number of viable oocytes post warming
within 5 minutes post warming

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fertilization rate
Time Frame: 18 hours post injection
number of zygotes post intracytoplasmic sperm injection procedure
18 hours post injection
blastulation rate
Time Frame: 4-6 days after fertilization
number of zygotes reaching the blastocyst stage of embryo development
4-6 days after fertilization
euploid rate
Time Frame: 1 week after trophectoderm biopsy
number of chromosomally normal embryos
1 week after trophectoderm biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2020

Primary Completion (Actual)

May 11, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 8, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

January 14, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMA-2020-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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