Oocyte Cryopreservation Registry (HOPE Registry)
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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 |
- Prospectively register and track the outcomes of cycles with frozen-thawed oocytes that are fertilized and transferred in subjects [ Time Frame: Multiple timepoints ] [ Designated as safety issue: No ]
- Identify factors associated with successful cycle outcomes and to monitor the child's health and development immediately after birth and at twelve (12) months of age, utilizing standard medical practices. [ Time Frame: Multiple timepoints ] [ Designated as safety issue: No ]
| 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 |
| Genders 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
Contacts and 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 | |
| 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 |
| Last Updated: | September 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 23, 2013