Oocyte Cryopreservation Registry (HOPE Registry) - Full Text View

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 60657
Research Site
Chicago, Illinois, United States, 60610
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

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 March 03, 2015