Clinical trial NCT00699400: Oocyte Cryopreservation Registry (HOPE Registry)
Official title: A Phase IV, Prospective, Multicenter, Observational Oocyte Cryopreservation Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oocyte Cryopreservation
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2008-06-18
Enrollment: 204
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women of reproductive age who, in order to achieve a pregnancy, will have embryos created from thawed autologously or heterologously implanted oocytes that were either:

* cryopreserved at the time of or following the Registry's launch, or
* cryopreserved prior to the Registry's launch, but will undergo thaw/fertilization/transfer procedures while the subject is enrolled in the Registry.

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.

Eligibility criteria: 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 outcomes:
measure: Thawing Cycle Level Live Birth Rate
timeFrame: Birth of one or more live babies
Secondary outcomes:
measure: Oocyte Level Live Birth Rate
timeFrame: Birth of one or more live babies
measure: Number of Live Babies
timeFrame: Birth of one or more live babies
measure: Number of Oocytes Frozen
timeFrame: At cryopreservation
measure: Number of Oocytes Thawed
timeFrame: At start of thawing cycle
measure: Oocyte Survival Rate
timeFrame: At time of fertilization
measure: Implantation Rate
timeFrame: At time of ultrasound after embryo transfer
measure: Number of Clinical Pregnancies
timeFrame: At time of ultrasound after embryo transfer
measure: Number of Miscarriages
timeFrame: Anytime after embryo transfer
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Research Site
state: California
city: Laguna Hills
country: United States
facility: Research Site
state: California
city: Newport Beach
country: United States
facility: Research Site
state: California
city: Santa Monica
country: United States
facility: Research Site
state: California
city: New Haven
country: United States
facility: Research Site
state: Connecticut
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Glenville
country: United States
facility: Research Site
state: Illinois
city: Rockland
country: United States
facility: US Local Med Info Office
state: Massachusetts
city: Waltham
country: United States
facility: Research Site
state: Massachusetts
city: Millburn
country: United States
facility: Research Site
state: New Jersey
city: New York
country: United States
facility: Research Stie
state: New York
city: bryn Mawr
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
affiliation: EMD Serono
name: Mary Mahony, PhD, HCLD (AAB)
role: STUDY_DIRECTOR
References:
citation: Nagy ZP, Anderson RE, Feinberg EC, Hayward B, Mahony MC. The Human Oocyte Preservation Experience (HOPE) Registry: evaluation of cryopreservation techniques and oocyte source on outcomes. Reprod Biol Endocrinol. 2017 Feb 7;15(1):10. doi: 10.1186/s12958-017-0228-7.