Oocyte Survival After Vitrification With Slush Nitrogen Compared With Liquid Nitrogen

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: Vitrification via slush nitrogen; Other: Vitrification via liquid nitrogen

• Registration Number: NCT04342364
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

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.

Study Timeline

• Study Start: 2020-04-08
• Study First Submitted: 2020-04-08
• Study First Submitted QC: 2020-04-08
• Study First Posted: 2020-04-13
• Primary Completion: 2021-05-11
• Study Completion: 2021-07-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Slush nitrogen	Vitrification via slush nitrogen	oocytes are randomized to undergo vitrification utilizing slush nitrogen
Liquid Nitrogen	Vitrification via liquid nitrogen	oocytes are randomized to undergo vitrification utilizing liquid nitrogen which is the current standard of care

Primary Outcome Measures

Name	Time	Method
oocyte survival rate	within 5 minutes post warming	number of viable oocytes post warming

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Reproductive Medicine Associates of New Jersey; 🇺🇸 Basking Ridge, New Jersey, United States