Phase IV, prospective multicenter, observational Registry will track cycle outcomes for subjects who are thawing frozen oocytes for subsequent use through in vitro fertilization (IVF) and embryo transfer (ET)
Subjects will be enrolled at as many ART clinics that offer oocyte cryopreservation and are willing to participate in the Registry. Oocytes will be retrieved and cryopreserved from autologous or heterologous donors. When the subject decides she would like to get pregnant, oocytes will be thawed, fertilized and the resultant embryos will be transferred to the oocyte donor (for autologous use) or to another recipient (for heterologous use). The treatment regimen will be completed with births and well-baby follow-up of children at 12 months of age. Information on children will be submitted by their parents to the Investigators. Data collection for the Registry will be active for a maximum of five (5) years, including three (3) years of enrollment and two (2) additional years to complete the well-baby follow-up for all the children.
Study Type
OBSERVATIONAL
Enrollment
204
Research Site
Fountain Valley, California, United States
Research Site
Laguna Hills, California, United States
Research Site
Newport Beach, California, United States
Thawing Cycle Level Live Birth Rate
Live birth rate per thawing cycle was calculated from the number of live births divided by the number of oocytes thawed less the number of embryos cryopreserved from thawed oocytes, averaged over all thawing cycles.
Time frame: Birth of one or more live babies
Oocyte Level Live Birth Rate
Oocyte Level Live Birth Rate was calculated from the total number of live births divided by the total number of oocytes thawed less the total number of embryos cryopreserved from thawed oocytes
Time frame: Birth of one or more live babies
Number of Live Babies
Time frame: Birth of one or more live babies
Number of Oocytes Frozen
Time frame: At cryopreservation
Number of Oocytes Thawed
Time frame: At start of thawing cycle
Oocyte Survival Rate
Number of oocytes fertilized divided by number of oocytes thawed per thawing cycle
Time frame: At time of fertilization
Implantation Rate
Implantation rate was calculated as the number of fetal sacs per transferred embryo averaged over all thawing cycles
Time frame: At time of ultrasound after embryo transfer
Number of Clinical Pregnancies
Number of clinical pregnancies defined as the presence of one or more fetal sacs with a heartbeat.
Time frame: At time of ultrasound after embryo transfer
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Research Site
Santa Monica, California, United States
Research Site
New Haven, Connecticut, United States
Research Site
Orlando, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Chicago, Illinois, United States
Research Site
Glenville, Illinois, United States
...and 5 more locations
Number of Miscarriages
Number of pregnancy outcomes reported as spontaneous abortions
Time frame: Anytime after embryo transfer