Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen

Not Applicable

Completed

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

• Registration Number: NCT04496284
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

Brief Summary

The proposed study is a single-blind randomized controlled trial which seeks to characterize implantation rates following embryo vitrification and subsequent warming with both slush nitrogen and liquid nitrogen. After warming, implantation rates and pregnancy outcomes will be assessed.

Detailed Description

The purpose of this study is to determine if slush nitrogen for embryo vitrification results in higher sustained implantation rates compared to the conventional use of liquid nitrogen. Routine ovarian stimulation, oocyte retrieval and embryology care will ensue. All blastocyst stage embryos will be randomized to either the control (liquid nitrogen) or intervention group (slush nitrogen) and vitrified after trophectoderm biopsy has been performed for PGT-A (preimplantation genetic testing for aneuploidy). A single, chromosomally normal embryo will be transferred in a subsequent frozen embryo transfer cycle per routine. Implantation rates and pregnancy outcomes will be assessed.

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-03
• Study Start: 2020-09-05
• Primary Completion: 2022-05-03
• Study Completion: 2022-12-20
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 253

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitrification via slush nitrogen	Vitrification via slush nitrogen	Blastocyst stage embryos will be vitrified via slush nitrogen

Primary Outcome Measures

Name	Time	Method
sustained implantation rate	approximately 8 weeks gestation age	fetal heart beat present upon discharge at 8 weeks

Secondary Outcome Measures

Name	Time	Method
clinical pregnancy rate	usually by 5 weeks gestational age	presence of gestational sac in uterus
miscarriage rate	1-8 months dependent on gestational age of loss	pregnancy loss
live birth rate	9 months	delivery of live infant

Trial Locations

Locations (1)

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