Oocyte Cryopreservation Registry (HOPE Registry)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00699400
First received: June 13, 2008
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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)


Condition
Oocyte Cryopreservation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase IV, Prospective, Multicenter, Observational Oocyte Cryopreservation Registry

Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Thawing Cycle Level Live Birth Rate [ Time Frame: Birth of one or more live babies ] [ Designated as safety issue: No ]
    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:
  • Oocyte Level Live Birth Rate [ Time Frame: Birth of one or more live babies ] [ Designated as safety issue: No ]
    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

  • Number of Live Babies [ Time Frame: Birth of one or more live babies ] [ Designated as safety issue: No ]
  • Number of Oocytes Frozen [ Time Frame: At cryopreservation ] [ Designated as safety issue: No ]
  • Number of Oocytes Thawed [ Time Frame: At start of thawing cycle ] [ Designated as safety issue: No ]
  • Oocyte Survival Rate [ Time Frame: At time of fertilization ] [ Designated as safety issue: No ]
    Number of oocytes fertilized divided by number of oocytes thawed per thawing cycle

  • Implantation Rate [ Time Frame: At time of ultrasound after embryo transfer ] [ Designated as safety issue: No ]
    Implantation rate was calculated as the number of fetal sacs per transferred embryo averaged over all thawing cycles

  • Number of Clinical Pregnancies [ Time Frame: At time of ultrasound after embryo transfer ] [ Designated as safety issue: No ]
    Number of clinical pregnancies defined as the presence of one or more fetal sacs with a heartbeat.

  • Number of Miscarriages [ Time Frame: Anytime after embryo transfer ] [ Designated as safety issue: No ]
    Number of pregnancy outcomes reported as spontaneous abortions


Enrollment: 204
Study Start Date: June 2008
Study Completion Date: July 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699400

Locations
United States, California
Research Site
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
United States, Connecticut
Research Site
New Haven, Connecticut, United States, 06511
United States, Florida
Research Site
Orlando, Florida, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
United States, Illinois
Research Site
Chicago, Illinois, United States, 60610
Research Site
Chicago, Illinois, United States, 60657
Research Site
Glenville, Illinois, United States, 60026
United States, Massachusetts
US Local Med Info Office
Rockland, Massachusetts, United States, 02370
Research Site
Waltham, Massachusetts, United States
United States, New Jersey
Research Site
Millburn, New Jersey, United States
United States, New York
Research Stie
New York, New York, United States
United States, Pennsylvania
Research Site
bryn Mawr, Pennsylvania, United States, 19101
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Mary Mahony, PhD, HCLD (AAB) EMD Serono, Inc.
  More Information

No publications provided

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00699400     History of Changes
Other Study ID Numbers: 28599
Study First Received: June 13, 2008
Results First Received: May 16, 2013
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014