The purpose of this research study is to evaluate a newly developed embryo culture media system for human clinical use in ART.
Egg retrieval will be performed as per standard operating procedures. Eggs from a single patient are mixed together in a single group during the normal recovery and washing procedure following egg retrieval. The single group of eggs will be divided in half, then the embryologist will randomly place each half into one of the two culture media treatments, commercial or experimental. All mature eggs collected at retrieval will undergo fertilization per standard operating procedures according to physician recommendations. After fertilization (day 0), standard procedures involve in vitro embryo culture in a sequential two step media system. After confirmation of fertilization success on day 1, embryos are cultured until day 3 in step 1 medium (both commercial and experimental media are two step sequential culture systems). On day 3, embryos are evaluated and moved from step one to step two culture medium. On day 5 and day 6, embryo development will be assessed. Good quality blastocysts will either be transferred fresh or cryopreserved for later transfer and/or genetic testing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Two step sequential embryo culture medium system
Fertility Laboratories of Colorado
Lone Tree, Colorado, United States
National Fooundation for Fertility Research
Lone Tree, Colorado, United States
embryo development
Blastocyst development and quality on days 5 and 6 of culture
Time frame: 7 days after egg retrieval
pregnancy rate
The incidence of implantation and pregnancy following embryo transfer, including initial pregnancy test and ultrasound examination.
Time frame: 2 months after egg retrieval
offspring weight
The birth weight of children born
Time frame: 1 year after egg retrieval
offspring gender
The gender of children born
Time frame: 1 year after egg retrieval
fertilization
the percentage of mature eggs that successfully fertilized normally
Time frame: 2 days after egg retrieval
euploid embryos
For patients undergoing comprehensive chromosome screening, percent normal euploid blastocysts
Time frame: 1 month after egg retrieval
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