Oocyte Cryopreservation Registry (HOPE Registry)
A Phase IV, Prospective, Multicenter, Observational Oocyte Cryopreservation Registry
1 other identifier
observational
204
1 country
15
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2008
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 13, 2008
CompletedFirst Posted
Study publicly available on registry
June 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
January 24, 2014
CompletedJanuary 24, 2014
December 1, 2013
3.9 years
June 13, 2008
May 16, 2013
December 9, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Thawing Cycle Level Live Birth Rate
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.
Birth of one or more live babies
Secondary Outcomes (8)
Oocyte Level Live Birth Rate
Birth of one or more live babies
Number of Live Babies
Birth of one or more live babies
Number of Oocytes Frozen
At cryopreservation
Number of Oocytes Thawed
At start of thawing cycle
Oocyte Survival Rate
At time of fertilization
- +3 more secondary outcomes
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EMD Seronolead
Study Sites (15)
Research Site
Fountain Valley, California, United States
Research Site
Laguna Hills, California, 92653, United States
Research Site
Newport Beach, California, United States
Research Site
Santa Monica, California, United States
Research Site
New Haven, Connecticut, 06511, United States
Research Site
Orlando, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Chicago, Illinois, 60610, United States
Research Site
Chicago, Illinois, 60657, United States
Research Site
Glenville, Illinois, 60026, United States
US Local Med Info Office
Rockland, Massachusetts, 02370, United States
Research Site
Waltham, Massachusetts, United States
Research Site
Millburn, New Jersey, United States
Research Stie
New York, New York, United States
Research Site
Bryn Mawr, Pennsylvania, 19101, United States
Related Publications (1)
Nagy ZP, Anderson RE, Feinberg EC, Hayward B, Mahony MC. The Human Oocyte Preservation Experience (HOPE) Registry: evaluation of cryopreservation techniques and oocyte source on outcomes. Reprod Biol Endocrinol. 2017 Feb 7;15(1):10. doi: 10.1186/s12958-017-0228-7.
PMID: 28173814DERIVED
Results Point of Contact
- Title
- Mary C. Mahony, PhD, HCLD (AAB)
- Organization
- EMD Serono, Inc.
Study Officials
- STUDY DIRECTOR
Mary Mahony, PhD, HCLD (AAB)
EMD Serono
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2008
First Posted
June 18, 2008
Study Start
June 1, 2008
Primary Completion
May 1, 2012
Study Completion
July 1, 2012
Last Updated
January 24, 2014
Results First Posted
January 24, 2014
Record last verified: 2013-12