Oocyte Cryopreservation Registry (HOPE Registry)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase IV, Prospective, Multicenter, Observational Oocyte Cryopreservation Registry

Conditions
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Oocyte Cryopreservation

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Birth of one or more live babies | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Birth of one or more live babies | 
| Number of Live Babies |  | Birth of one or more live babies | 
| Number of Oocytes Frozen |  | At cryopreservation | 
| Number of Oocytes Thawed |  | At start of thawing cycle | 
| Oocyte Survival Rate | Number of oocytes fertilized divided by number of oocytes thawed per thawing cycle | At time of fertilization | 
| Implantation Rate | Implantation rate was calculated as the number of fetal sacs per transferred embryo averaged over all thawing cycles | 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. | At time of ultrasound after embryo transfer | 
| Number of Miscarriages | Number of pregnancy outcomes reported as spontaneous abortions | Anytime after embryo transfer |