Evaluation of the Impact of Reduced Oxygen Concentration on Live Birth Rate

Completed · Not applicable

Conditions studied: Infertility

In brief

Clinical in vitro fertilization relies on successful embryo culture. The primary goal of embryo culture is to attempt to recapitulate the in vivo conditions as much as possible. In the past decade, the majority embryo culture has been performed at 5% oxygen due to the discovery that the oxygen tension in the fallopian tube (where the embryo is located for the first 3 days after fertilization) is 5%. However, relatively recent studies have demonstrated that the oxygen tension in the uterus (where the embryo is located after day 3) is closer to 2%. This study is a randomized controlled trial that will compare pregnancy rates between embryos cultured in 2% versus 5% after day 3 of development.

Key facts

Study ID

NCT03147872

Run by

Reproductive Medicine Associates of New Jersey

People needed

280

Starts

2017-05-15

Expected to finish

2021-01-31

Last updated by the study team

2021-05-19

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Anti-mullerian hormone level (AMH) > 1.0 ng/mL
• Must have at least one surviving embryo on day three of development
• Male partner with >100,000 total motile spermatozoa per ejaculate (donor sperm acceptable)
• Body Mass Index < 35

You may not qualify if…

• Diagnosis of endometrial insufficiency, as defined by prior cycle with maximal endometrial thickness <6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), or persistent endometrial fluid
• Use of oocyte donation
• Use of gestational carrier
• Use of sperm obtained via surgical procedure
• Presence of hydrosalpinges that communicate with endometrial cavity
• Single gene disorders, chromosomal translocations or any other disorders requiring more detailed embryo genetic analysis
• Couples seeking gender selection for family balancing
• Completion of the protocol requires a single embryo transfer of an embryo as part of the study. Thus, patients pursuing embryo banking cycles will be excluded from the study.
• Double embryo transfer

Where it is running

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

Full record on ClinicalTrials.gov

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