The Effect of Embryo Culture Under a Continuous CO2 Setti... | NCT04693806

Studies
The Effect of Embryo Culture Under a Continuous CO2 Setting Versus a Sequential CO2 Setting

NCT04693806

Sponsor

Reproductive Medicine Associates of New Jersey

Status

Completed

Last Update Posted

May 3, 2023Actual

Enrollment

102Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

Continuous CO2 Level

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

Dec 3, 2020Actual

Primary Completion Date

Jan 11, 2021Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

Dec 30, 2020

First Submission Date that Met QC Criteria

Dec 31, 2020

First Posted Date

Jan 5, 2021Actual

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

Detailed Description

Following enrollment, patients will undergo ovarian stimulation and oocyte retrieval per routine as previously consented to at the clinic. IVF stimulation protocol will be at the discretion of the patient's individual provider, per routine. Intracytoplasmic Sperm Injection (ICSI) will be performed and embryos will be cultured to the blastocyst stage per routine. There are no changes to the embryology care itself, the only difference within the study is the CO2 level within the incubator pending the patient's randomization.

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

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Continuous CO2 Level	Other	Embryos will be cultured in a single, continuous CO2 setting	Continuous CO2 Level

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
blastulation rate	the number of zygotes that reach the blastocyst stage	approximately one week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Major Inclusion Criteria for participants:

1. Patients undergoing IVF stimulation cycle with plan for subsequent FET

Major Exclusion Criteria for participants:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided