Oocyte CryopreservationNCT00699400
Oocyte Cryopreservation Registry (HOPE Registry)
An observational study of Oocyte Cryopreservation, run by EMD Serono at 15 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oocyte Cryopreservation
- How many people
- 204 participants
- Where
- 15 sitesUnited States
- Study dates
- Jun 2008to Jul 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Research Site
Atlanta, Georgia
Research Site
Bryn Mawr, Pennsylvania, 19101
Research Site
Chicago, Illinois, 60610
Research Site
Chicago, Illinois, 60657
Research Site
Fountain Valley, California
Research Site
Glenville, Illinois, 60026
Research Site
Laguna Hills, California, 92653
Research Site
Millburn, New Jersey
Research Site
New Haven, Connecticut, 06511
Research Stie
New York, New York
Research Site
Newport Beach, California
Research Site
Orlando, Florida
US Local Med Info Office
Rockland, Massachusetts, 02370
Research Site
Santa Monica, California
Research Site
Waltham, Massachusetts
About this study
Official title: A Phase IV, Prospective, Multicenter, Observational Oocyte Cryopreservation Registry
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)
Read the 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.
- Conditions
- Oocyte Cryopreservation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Birth of one or more live babies
Secondary outcomes (8)
Oocyte Level Live Birth Rate
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
Measured: Birth of one or more live babies
Number of Live Babies
Measured: Birth of one or more live babies
Number of Oocytes Frozen
Measured: At cryopreservation
Number of Oocytes Thawed
Measured: At start of thawing cycle
Oocyte Survival Rate
Number of oocytes fertilized divided by number of oocytes thawed per thawing cycle
Measured: At time of fertilization
Implantation Rate
Implantation rate was calculated as the number of fetal sacs per transferred embryo averaged over all thawing cycles
Measured: At time of ultrasound after embryo transfer
Number of Clinical Pregnancies
Number of clinical pregnancies defined as the presence of one or more fetal sacs with a heartbeat.
Measured: At time of ultrasound after embryo transfer
Number of Miscarriages
Number of pregnancy outcomes reported as spontaneous abortions
Measured: Anytime after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionMay 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oocyte CryopreservationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Mahony, PhD, HCLD (AAB), Study director, EMD Serono
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699400
- Sponsor's protocol ID
- 28599
- Status last verified
- Dec 2013
- First submitted
- 13 Jun 2008
- Last updated
- 24 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 28173814
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Prospective, Multicenter, Observational Oocyte Cryopreservation Registry
- ClinicalTrials.gov ID
- NCT00699400
- Acronym / sponsor ID
- 28599
- Conditions
- Oocyte Cryopreservation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 18 Jun 2008 (estimated)
- Results
- Posted 24 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Oocyte Level Live Birth Rate
Time frame: Birth of one or more live babies
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
Implantation Rate
Time frame: At time of ultrasound after embryo transfer
Number of Clinical Pregnancies
Time frame: At time of ultrasound after embryo transfer
Number of Miscarriages
Time frame: Anytime after embryo transfer
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28173814Nagy 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.
Related trials for Oocyte Cryopreservation
RecruitingObservational study
Follicular Flushing Versus Direct Aspiration in Transabdominal Oocyte Retrieval
Fertility Preservation
RecruitingObservational study
Ovarian Tissue Cryopreservation Combined With Oocyte Cryopreservation Versus Oocyte Cryopreservation Alone
Oncological Disease, Fertility Preservation
Not yet recruiting
Decision Aid for Elective Egg Freezing
Elective Egg Freezing, Oocyte Cryopreservation
Recruiting
Virtual Reality Intervention to Reduce Pain in Women Undergoing Elective Oocyte Cryopreservation
Procedure-Related Pain, Acute Pain
Active, not recruiting
Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Mahony, PhD, HCLD (AAB) study director
EMD Serono
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oocyte Cryopreservation, run by EMD Serono at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thawing Cycle Level Live Birth Rate (time frame: Birth of one or more live babies). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00699400, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2014.