Infertility Clinical Trial
Official title:
Randomized Controlled Open-Label Non-Inferiority Trial Comparing Day 5 Embryos Derived From Intravaginal Culture Using the Medical Device INVOcell to Traditional In Vitro Fertilization
The purpose of this study is to evaluate intravaginal culture using the medical device INVOcell to generate day 5 blastocysts in comparison to traditional IVF.
This is a Phase III, single center, open label randomized comparative trial to evaluate
intravaginal culture using INVOcell vs. traditional IVF to generate day 5 embryos Pilot: 40
couples (80 patients), randomized to receive either intravaginal culture (n=20) using the
INVOcell or traditional IVF (n=20) Primary Endpoints: Blastocyst generation rate: number of
day 5 embryos of "good quality" defined as 2BB or greater (expansion of embryo 2,3,4,5 or 6
and inner cell mass and outer cell mass grades of A or B) or higher using the Gardner
Grading System divided by the number of eggs incubated Patient acceptability of INVOcell and
intravaginal culture.
Secondary Endpoints: Live birth rate: number of cycles with a live birth divided by the
number of cycles with embryo transfers.
Clinical pregnancy rate: number of cycles with fetal heartbeat at week 7 divided by the
number of cycles with embryo transfers.
Fertilization rate: Number of embryos obtained after incubation divided by the number of
oocytes placed in the device.
Embryo transfer rate: Number of cycles initiated divided by the number of cycles with embryo
transfers Miscarriage rate: Number of miscarriages divided by the number of cycles with
embryo transfers Multiple rate: Number cycles with twins or triplets divided by the number
of cycles with embryo transfers Miscarriage rate per clinical pregnancy: Number of
miscarriages divided by the number of cycles with clinical pregnancy
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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