Oocyte Cryopreservation Registry (HOPE Registry)

Completed

Brief Summary: 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)

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Must be in an ART program
Donor and recipients must be of reproductive age (18-50 years old, inclusive at the time of oocyte freezing and/or thawing) who intend to achieve a pregnancy by utilizing frozen thawed autologous or heterologous oocytes
Female and partner (if applicable) must voluntarily provide written informed consent/HIPAA authorization prior to any Registry-related data collection
Female and partner (if applicable) must be willing to provide a second written informed consent following each live birth prior to any Registry- related data collection on birth characteristics and twelve (12) month evaluation of offspring
Children born from women who take part in this registry from birth to 12 months (+/- 1 month) of age

Exclusion Criteria

Have clinically significant systemic disease
Have abnormal, undiagnosed gynecological bleeding
Have any contraindication to Controlled Ovarian Stimulation (COS) for ART and to gonadotropins to be used in ART
Also, in a rare situation, are undergoing ET with mixed embryos generated from fresh oocytes produced in the current cycle as well as frozen embryos generated from nonfrozen oocytes obtained in a previous ART cycle
Children born from women who do not take part in this Registry
Any offspring of woman who are not Registry subjects cannot take part in this registry

Primary Outcome Measures

Name	Time	Method
Thawing Cycle Level Live Birth Rate	Birth of one or more live babies	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.

Secondary Outcome Measures

Name	Time	Method
Number of Oocytes Thawed	At start of thawing cycle
Oocyte Level Live Birth Rate	Birth of one or more live babies	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
Implantation Rate	At time of ultrasound after embryo transfer	Implantation rate was calculated as the number of fetal sacs per transferred embryo averaged over all thawing cycles
Number of Miscarriages	Anytime after embryo transfer	Number of pregnancy outcomes reported as spontaneous abortions
Number of Live Babies	Birth of one or more live babies
Number of Oocytes Frozen	At cryopreservation
Oocyte Survival Rate	At time of fertilization	Number of oocytes fertilized divided by number of oocytes thawed per thawing cycle
Number of Clinical Pregnancies	At time of ultrasound after embryo transfer	Number of clinical pregnancies defined as the presence of one or more fetal sacs with a heartbeat.

Locations (3): Research Site
🇺🇸
bryn Mawr, Pennsylvania, United States
Research Stie
🇺🇸
New York, New York, United States
US Local Med Info Office
🇺🇸
Rockland, Massachusetts, United States