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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)
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Birth of one or more live babies |
| Number of Live Babies |
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Inclusion Criteria:
Exclusion Criteria:
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Mahony, PhD, HCLD (AAB) | EMD Serono | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fountain Valley | California | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28173814 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Slow Freeze (One Cycle) | Subjects who participated in one freezing cycle of the Registry only using the slow freeze technique (i.e. freezing that occurs at a slow rate to minimize ice formation) |
| FG001 | Slow Freeze (Two Cycles) | Subjects who participated in two freezing cycles of the Registry only using the slow freeze technique (i.e. freezing that occurs at a slow rate to minimize ice formation) |
| FG002 | Vitrification (One Cycle) | Subjects who participated in one freezing cycle of the Registry only using the vitrification technique (i.e. cryopreservation using high initial concentrations of cryoprotectant and ultra rapid cooling to solidify the cell without the formation of ice) |
| FG003 | Vitrification (Two Cycles) | Subjects who participated in two freezing cycles of the Registry only using the vitrification technique (i.e. cryopreservation using high initial concentrations of cryoprotectant and ultra rapid cooling to solidify the cell without the formation of ice) |
| FG004 | Both (Slow Freeze and Vitrification) | Participants who underwent both slow freezing and vitrification cycles (one cycle of each freezing technique). |
| FG005 | Pre-freeze Discontinuations | Participants who enrolled in the study but withdrew before oocyte retrieval or for whom oocyte retrieval failed (had no oocytes to freeze). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects were analyzed based on the freeze cycle(s) that were used, therefore, the 4 subjects that used both types of cryopreservation techniques are summarized in both the slow freeze and vitrification arms. These 4 subjects will be double-counted in the "Total (calculated)" column.
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| ID | Title | Description |
|---|---|---|
| BG000 | Slow Freeze | Subjects that participated in one or more slow-freeze cycles |
| BG001 | Vitrification | Subjects that participated in one or more vitrification cycles |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Four subjects underwent cryopreservation cycles for both slow-freezing and vitrification 11 Participants who enrolled in the study but withdrew before oocyte retrieval or for whom oocyte retrieval failed (had no oocytes to freeze) are captured in the Pre-Freeze Discontinuation Arm. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Live birth rate per thaw cycle(%) | Posted | Mean | 95% Confidence Interval | % of oocytes thawed per cycle | Birth of one or more live babies | Thawing Cycles | Participants |
|
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Adverse events were not collected during the study. No deaths occurred during the course of the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Slow Freezing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary C. Mahony, PhD, HCLD (AAB) | EMD Serono, Inc. | 781.681.2438 | mary.mahony@emdserono.com |
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| 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 | Number of oocytes fertilized divided by number of oocytes thawed per thawing cycle | At time of fertilization |
| Implantation Rate | Implantation rate was calculated as the number of fetal sacs per transferred embryo averaged over all thawing cycles | 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. | At time of ultrasound after embryo transfer |
| Number of Miscarriages | Number of pregnancy outcomes reported as spontaneous abortions | Anytime after embryo transfer |
| 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 |
| BG002 | Pre-Freeze Discontinuations | Participants who enrolled in the study but withdrew before oocyte retrieval or for whom oocyte retrieval failed (had no oocytes to freeze). |
| BG003 | Total | Total of all reporting groups |
| Number |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | Kg/m^2 |
|
| Donor Age | Mean | Standard Deviation | Years |
|
|
|
| Secondary | 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 | Posted | Number | % of all oocytes thawed | Birth of one or more live babies | Thawed Oocytes - Cryopreserved Embryos | Participants |
|
|
|
| Secondary | Number of Live Babies | Posted | Number | Number of live births | Birth of one or more live babies |
|
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| Secondary | Number of Oocytes Frozen | Posted | Number | Number of Oocytes Frozen | At cryopreservation | Freezing Cycles | Participants |
|
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| Secondary | Number of Oocytes Thawed | Posted | Number | Number of oocytes thawed | At start of thawing cycle | Thawing Cycles | Participants |
|
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| Secondary | Oocyte Survival Rate | Number of oocytes fertilized divided by number of oocytes thawed per thawing cycle | Posted | Mean | Standard Deviation | Oocyte survival rate (%) | At time of fertilization | Thawing cycles | Participants |
|
|
|
| Secondary | Implantation Rate | Implantation rate was calculated as the number of fetal sacs per transferred embryo averaged over all thawing cycles | Posted | Mean | Standard Deviation | Implantation Rate (%) | At time of ultrasound after embryo transfer | Thawing Cycles | Participants |
|
|
|
| Secondary | Number of Clinical Pregnancies | Number of clinical pregnancies defined as the presence of one or more fetal sacs with a heartbeat. | Participants could have multiple thawing cycles that could lead to multiple embryo transfers. Only successful thaws lead to embryo transfers and only successful embryo transfers lead to clinical pregnancies. | Posted | Number | Number of Clinical Pregnancies | At time of ultrasound after embryo transfer | Embryo Transfers | Participants |
|
|
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| Secondary | Number of Miscarriages | Number of pregnancy outcomes reported as spontaneous abortions | Participants could have multiple thawing cycles that could lead to multiple embryo transfers. Only successful thaws lead to embryo transfers and only successful embryo transfers lead to clinical pregnancies. | Posted | Number | Number of Miscarriages | Anytime after embryo transfer | Embryo Transfers | Participants |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Vitrification | 0 | 0 | 0 | 0 |
| EG002 | All Participants | 0 | 0 | 0 | 0 |
Institution and Principal Investigator may disclose confidential information to the extent required by law or court order, provided that they promptly provide to EMD Serono prior notice of such disclosure and provide assistance in obtaining an order protecting Confidential Information from public disclosure.