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

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

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Other: Continuous CO2 Level

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Reproductive Medicine Associates of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous CO2 Level; embryos will remain in a single incubator set at a continuousCO2 level	Other: Continuous CO2 Level; Embryos will be cultured in a single, continuous CO2 setting
No Intervention: Sequential CO2 Level; Current standard of care

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Reproductive Medicine Associates of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Actual): January 11, 2021
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: December 31, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: RMA-2020-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No