NCT04693806

Brief Summary

The purpose of this study is to determine if embryo culture under a single CO2 setting improves blastocyst formation rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

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

Study Start

First participant enrolled

December 3, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

1 month

First QC Date

December 30, 2020

Last Update Submit

May 2, 2023

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • blastulation rate

    the number of zygotes that reach the blastocyst stage

    approximately one week

Study Arms (2)

Continuous CO2 Level

EXPERIMENTAL

embryos will remain in a single incubator set at a continuousCO2 level

Other: Continuous CO2 Level

Sequential CO2 Level

NO INTERVENTION

Current standard of care

Interventions

Continuous CO2 LevelOTHER

Embryos will be cultured in a single, continuous CO2 setting

Continuous CO2 Level

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Patients undergoing IVF stimulation cycle with plan for subsequent FET

You may not qualify if:

  • All patients who do not voluntarily give their written consent for participation
  • Male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
  • Use of surgical procedures to obtain sperm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

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

December 30, 2020

First Posted

January 5, 2021

Study Start

December 3, 2020

Primary Completion

January 11, 2021

Study Completion

April 30, 2022

Last Updated

May 3, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)