Oocyte Survival After Vitrification With Slush Nitrogen Compared With Liquid Nitrogen

Infertility Clinical Trial

Official title:

Oocyte Survival After Vitrification With Slush Nitrogen Compared With Liquid Nitrogen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342364
• Other study ID #: RMA-2020-02
• Status: Completed
• Phase: N/A
• Start date: April 8, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: January 2022
• Source: Reproductive Medicine Associates of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 1, 2021
• Est. primary completion date: May 11, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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).

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Vitrification via slush nitrogen
oocytes will be vitrified using slush nitrogen
• Vitrification via liquid nitrogen
oocytes will be vitrified using liquid nitrogen which is currently routine practice

Locations

Country	Name	City	State
United States	Reproductive Medicine Associates of New Jersey	Basking Ridge	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oocyte survival rate	number of viable oocytes post warming	within 5 minutes post warming
Secondary	fertilization rate	number of zygotes post intracytoplasmic sperm injection procedure	18 hours post injection
Secondary	blastulation rate	number of zygotes reaching the blastocyst stage of embryo development	4-6 days after fertilization
Secondary	euploid rate	number of chromosomally normal embryos	1 week after trophectoderm biopsy