- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04342364
Oocyte Survival After Vitrification With Slush Nitrogen Compared With Liquid Nitrogen
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Reproductive Medicine Associates of New Jersey
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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