The Effects of Physiologic Oxygen Tension on Clinical In Vitro Fertilization Outcomes (PhOx)

Yale University

Status and phase

Completed

Phase 3

Conditions

Infertility

Pregnancy

Treatments

Procedure: Physiologic oxygen tension

Procedure: Atmospheric oxygen tension

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01010386

RMN-PhOx

Details and patient eligibility

About

Primary Aim

Evaluate whether human embryo exposure to physiologic levels of oxygen during culture improves the percentage of women who deliver a baby following in vitro fertilization and embryo transfer.

Hypothesis to be tested: Physiologic oxygen tension during embryo culture, which approximates the oxygen tension in the fallopian tube and uterus, improves live birth rate in clinical In Vitro Fertilization Embryo Transfer (IVF-ET).

Secondary Aims

Evaluate whether human embryo exposure to physiologic levels of oxygen during culture during in vitro fertilization and embryo transfer

improves embryo cleavage
improves clinical pregnancy rate
reduces multiple pregnancy rate
reduces miscarriage rate

Hypothesis to be tested: Physiologic oxygen tension during embryo culture, which approximates the oxygen tension in the fallopian tube and uterus, improves embryo cleavage and clinical pregnancy rates and reduces miscarriage rates in clinical IVF-ET.

Full description

Study Design

This will be a multi-center, prospective, double-blind clinical trial of physiologic (5%) oxygen tension in culture media vs. standard of care, atmospheric (SOC, 20%) oxygen tension with 840 eligible couples recruited to participate. The randomization scheme will be coordinated through the central data coordinating center (DCC-Yale) and the randomization will be stratified by age group of the woman (18-34, 35-37, 38-40 and 40-42) and each participating site.

Treatment

Couples will be randomized to either have their gametes and embryos placed in a physiologic (5%) oxygen atmosphere or in the currently widely used atmospheric (20%) oxygen atmosphere.

Enrollment

851 patients

Sex

All

Ages

18 to 42 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The critical inclusion criteria will be the diagnosis of infertility and the need for in vitro fertilization as determined by the treating clinician. (We do not plan to alter the standard of care for the indication for IVF at any of the sites.)

Couple's age must be between 18 and 42 years old
Patient and partner are scheduled to undergo in vitro fertilization for treatment of infertility
Couple able to participate in a research project and A) Able to understand study requirements B) Willing to sign informed consent C) Able to return for required follow-up D) Have access to telephone

Exclusion criteria

Critical exclusion criteria for this trial will be medical conditions which may complicate treatment or no plans to undergo embryo transfer, as in patients banking embryos prior to cancer therapy. In addition, donor egg and frozen embryo transfer cycles will be excluded.

Medical contraindication to egg retrieval or pregnancy
Inability to participate in a research project (Non-English speaking or unable to read or write and/or concurrent participation in any other interventional trial)
Couple with more than three previous failed IVF cycles
Donor egg and frozen embryo transfer cycles