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

Reproductive Medicine Associates of New Jersey

Status: Completed

Conditions: Infertility

Treatments: Other: Continuous CO2 Level

Study type: Interventional

Funder types: Other

Identifiers

NCT04693806

RMA-2020-04

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 2 patient groups

Continuous CO2 Level

Experimental group

Description:

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

Treatment:

Other: Continuous CO2 Level

Sequential CO2 Level

No Intervention group

Description:

Current standard of care