NCT04496284

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
253

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 3, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 5, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

1.7 years

First QC Date

July 28, 2020

Last Update Submit

May 2, 2023

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • sustained implantation rate

    fetal heart beat present upon discharge at 8 weeks

    approximately 8 weeks gestation age

Secondary Outcomes (3)

  • clinical pregnancy rate

    usually by 5 weeks gestational age

  • miscarriage rate

    1-8 months dependent on gestational age of loss

  • live birth rate

    9 months

Study Arms (2)

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

Vitrification via slush nitrogenOTHER

blastocyst stage embryos will be vitrified via slush nitrogen

Vitrification via slush nitrogen

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medicine Assoicates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

Related Publications (1)

  • 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.

    PMID: 39836897DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2020

First Posted

August 3, 2020

Study Start

September 5, 2020

Primary Completion

May 3, 2022

Study Completion

December 20, 2022

Last Updated

May 3, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)