Evaluation of the Impact of Reduced Oxygen Concentration on Embryonic Development
Completed · Not applicable
Conditions studied: Infertility
In brief
During this study, patients will undergo a routine in vitro fertilization cycle as they would otherwise if not participating in the study. After eggs have been fertilized they will be cultured as usual until day 3 of embryo development. On day 3 of development, the embryologist will randomize half of the embryos to be cultured in 2% oxygen concentration and the other half at 5%, which is currently the standard of care. All other embryological care procedures will remain the same. On day 5 or 6 of embryo development, the embryos will be evaluated and each blastocyst stage embryo will be recorded. The primary outcome will be the blastulation rate (or percentage of embryos that reach the blastocyst stage).
Key facts
- Study ID
- NCT02919384
- Run by
- Reproductive Medicine Associates of New Jersey
- People needed
- 60
- Starts
- 2016-10-06
- Expected to finish
- 2018-05-01
- Last updated by the study team
- 2018-06-26
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Age 18-40 years and seeking IVF with aneuploidy screening, which is our current recommendation regardless of study participation
- Anti-mullerian hormone level (AMH) > 1.0 pmol/L (an assessment of ovarian reserve)
- Must have at least two surviving embryos on day 3 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
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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