Oocyte Cryopreservation Registry (HOPE Registry)

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

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)

Study Overview

• Status: Completed
• Conditions: Oocyte Cryopreservation

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.

• Study Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• United States
  • California
    • Fountain Valley, California, United States
      • Research Site
    • Laguna Hills, California, United States, 92653
      • Research Site
    • Newport Beach, California, United States
      • Research Site
    • Santa Monica, California, United States
      • Research Site
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Research Site
  • Florida
    • Orlando, Florida, United States
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60610
      • Research Site
    • Chicago, Illinois, United States, 60657
      • Research Site
    • Glenville, Illinois, United States, 60026
      • Research Site
  • Massachusetts
    • Rockland, Massachusetts, United States, 02370
      • US Local Med Info Office
    • Waltham, Massachusetts, United States
      • Research Site
  • New Jersey
    • Millburn, New Jersey, United States
      • Research Site
  • New York
    • New York, New York, United States
      • Research Stie
  • Pennsylvania
    • bryn Mawr, Pennsylvania, United States, 19101
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: EMD Serono
• Investigators: Study Director: Mary Mahony, PhD, HCLD (AAB), EMD Serono

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (ACTUAL): May 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: June 13, 2008
• First Submitted That Met QC Criteria: June 13, 2008
• First Posted (ESTIMATE): June 18, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): January 24, 2014
• Last Update Submitted That Met QC Criteria: December 9, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 28599