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Oocyte Cryopreservation Registry (HOPE Registry)
This study has been completed.
Sponsor:
EMD Serono
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
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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 ]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 ]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
| 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) |
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 (Adult) |
| Sexes 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
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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
ClinicalTrials.gov processed this record on August 18, 2017