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NCT04693806 Clinical Trial

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

Infertility Clinical Trial

Official title:
The Effect of Embryo Culture Under a Continuous CO2 Setting Versus a Sequential CO2 Setting

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04693806
Other study ID # RMA-2020-04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 3, 2020
Est. completion date April 30, 2022

Study information
Verified date May 2023
Source Reproductive Medicine Associates of New Jersey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date April 30, 2022
Est. primary completion date January 11, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Major Inclusion Criteria for participants: 1. Patients undergoing IVF stimulation cycle with plan for subsequent FET Major Exclusion Criteria for participants: 1. All patients who do not voluntarily give their written consent for participation 2. Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable) 3. Use of surgical procedures to obtain sperm

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Continuous CO2 Level
Embryos will be cultured in a single, continuous CO2 setting

Locations
Country Name City State
United States Reproductive Medicine Associates of New Jersey Basking Ridge New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary blastulation rate the number of zygotes that reach the blastocyst stage approximately one week
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