Embryo Transfer Outcomes After Vitrification With Slush N... | NCT04496284

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

NCT04496284

Sponsor

Reproductive Medicine Associates of New Jersey

Status

Completed

Last Update Posted

May 3, 2023Actual

Enrollment

253Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

Vitrification via slush nitrogen

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 5, 2020Actual

Primary Completion Date

May 3, 2022Actual

Completion Date

Dec 20, 2022Actual

First Submitted Date

Jul 28, 2020

First Submission Date that Met QC Criteria

Jul 31, 2020

First Posted Date

Aug 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2023

Last Update Posted Date

May 3, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

253Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitrification via slush nitrogen	Experimental	Blastocyst stage embryos will be vitrified via slush nitrogen	Other: Vitrification via slush nitrogen
Vitrification via liquid nitrogen	No Intervention	Blastocyst stage embryos will be vitrified via conventional liquid nitrogen. This is the current standard of care.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitrification via slush nitrogen	Other	blastocyst stage embryos will be vitrified via slush nitrogen	Vitrification via slush nitrogen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sustained implantation rate	fetal heart beat present upon discharge at 8 weeks	approximately 8 weeks gestation age

Secondary Outcomes

Measure	Description	Time Frame
clinical pregnancy rate	presence of gestational sac in uterus	usually by 5 weeks gestational age
miscarriage rate	pregnancy loss

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Major Inclusion Criteria for participants:

Patients undergoing IVF stimulation cycle with plan for subsequent frozen embryo transfer (FET)
Patients electing preimplantation genetic testing for aneuploidy (PGT-A)
Couples electing single embryo transfer (SET)

Major Exclusion Criteria for participants:

All patients who do not voluntarily give their written consent for participation
Under 18 years old, above 42 years old
BMI > 35
Maximum day 3 Follicle stimulating hormone (FSH) level of 12 or higher
Anti-mullerian hormone (AMH) level less than 1.0 g/mL, tested within previous year
Total basal antral follicle count less than 6 follicles
Failed more than one previous FET cycle
Use of oocyte donation
Use of gestational carrier
Presence of hydrosalpinges that communicate with endometrial cavity
Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
Uncorrected uterine factor infertility (uterine anomaly, submucosal myomas, uterine septum)
Single gene disorder chromosomal rearrangement requiring a more detailed embryonic genetic analysis
Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
Use of surgical procedures to obtain sperm
Couples undergoing IVF for fertility preservation with no immediate plan for subsequent FET (embryo banking)
Sex selection
Personal history of repeated pregnancy loss (two or more unexplained clinical losses defined by presence of fetal heartbeat)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Reproductive Medicine Assoicates of New Jersey		Basking Ridge	New Jersey	07920	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39836897	Derived	Klimczak AM, Osman E, Esbert M, Yildirim RM, Whitehead C, Herlihy NS, Hanson BM, Roberts LM, Seli E, Scott RT Jr. A randomized controlled trial comparing embryo vitrification with slush nitrogen to liquid nitrogen in women undergoing frozen embryo transfer: embryology and clinical outcomes. Hum Reprod. 2025 Mar 1;40(3):426-433. doi: 10.1093/humrep/deaf003.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases