Embryo Culture medium
DeviceTwo step sequential embryo culture medium system
NCT Number: NCT02457481
The purpose of this research study is to evaluate a newly developed embryo culture media system for human clinical use in ART.
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Notify Me18 year and older
Female
Interventional
Not applicable
Fertility Laboratories of Colorado, Lone Tree, Colorado, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two step sequential embryo culture medium system
Time frame: 7 days after egg retrieval
Blastocyst development and quality on days 5 and 6 of culture
Time frame: 2 months after egg retrieval
The incidence of implantation and pregnancy following embryo transfer, including initial pregnancy test and ultrasound examination.
Time frame: 1 year after egg retrieval
The birth weight of children born
Time frame: 1 year after egg retrieval
The gender of children born
Time frame: 2 days after egg retrieval
the percentage of mature eggs that successfully fertilized normally
Time frame: 1 month after egg retrieval
For patients undergoing comprehensive chromosome screening, percent normal euploid blastocysts
National Foundation for Fertility Research
Other
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