Oocyte Cryopreservation Registry (HOPE Registry)
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ClinicalTrials.gov Identifier: NCT00699400 |
Recruitment Status :
Completed
First Posted : June 18, 2008
Results First Posted : January 24, 2014
Last Update Posted : January 24, 2014
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Condition or disease |
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Oocyte Cryopreservation |
Study Type : | Observational |
Actual Enrollment : | 204 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Phase IV, Prospective, Multicenter, Observational Oocyte Cryopreservation Registry |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | July 2012 |
- Thawing Cycle Level Live Birth Rate [ Time Frame: Birth of one or more live babies ]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.
- Oocyte Level Live Birth Rate [ Time Frame: Birth of one or more live babies ]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 ]
- Number of Oocytes Frozen [ Time Frame: At cryopreservation ]
- Number of Oocytes Thawed [ Time Frame: At start of thawing cycle ]
- Oocyte Survival Rate [ Time Frame: At time of fertilization ]Number of oocytes fertilized divided by number of oocytes thawed per thawing cycle
- Implantation Rate [ Time Frame: At time of ultrasound after embryo transfer ]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 ]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 ]Number of pregnancy outcomes reported as spontaneous abortions

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699400
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 |
Study Director: | Mary Mahony, PhD, HCLD (AAB) | EMD Serono |
Responsible Party: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00699400 |
Other Study ID Numbers: |
28599 |
First Posted: | June 18, 2008 Key Record Dates |
Results First Posted: | January 24, 2014 |
Last Update Posted: | January 24, 2014 |
Last Verified: | December 2013 |