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Slow enrollment and Natera is transitioning to a new PGS testing platform.
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| Name | Class |
|---|---|
| Ferring Pharmaceuticals | INDUSTRY |
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Natera is recruiting patients for a research study evaluating pregnancy and implantation rates in women undergoing In Vitro Fertilization (IVF) and Preimplantation Genetic Screening (PGS). PGS is also referred to as Preimplantation Genetic Diagnosis (PGD) for aneuploidy.
Healthy women undergoing IVF who are between the ages of 35 to 42 years are being recruited to participate in a randomized study.
The purpose of this study is to determine whether PGS- testing of embryos created during IVF for chromosomal abnormalities, prior to transfer to the uterus- improves pregnancy and implantation rates in patients when compared to patients whose embryos are not tested. PGS will be conducted using 24 Chromosome Aneuploidy Screening with Parental Support from Natera.
All subjects who qualify and enroll will receive discounted IVF medications (both TEST and CONTROL arms). If you become pregnant during the study, you will receive a small payment for providing information about your pregnancy and birth. If you are assigned to the TEST arm of the study you will receive free PGS.
If you meet the criteria below, you may be a candidate for this study. To participate in the study you must:
Additional screening will be conducted to determine if you are eligible to enroll.
All subjects who qualify and enroll will receive discounted IVF medications. If you become pregnant during the study, you will receive a small payment for providing information about your pregnancy and birth. If you are assigned to the TEST arm of the study you will receive free PGS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTROL arm | No Intervention | Subjects assigned to this arm of the study will receive no PGS testing. | |
| TEST arm | Other | Subjects assigned to this arm of the study will receive PGS testing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 24 Chromosome Aneuploidy Screening with Parental Support | Device | Preimplantation Genetic Screening (PGS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implantation Rate | Implantation rate is defined as the ratio between the number of gestational sacs with a fetal heartbeat and the total number of embryos transferred. | Data is collected at approximately 4-6 weeks gestation, 20 weeks gestation and 40 weeks gestation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntington Reproductive Center | Laguna Hills | California | 92653 | United States | ||
| Shady Grove Fertility RSC |
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| ID | Title | Description |
|---|---|---|
| FG000 | CONTROL Arm | Subjects assigned to this arm of the study will receive no PGS testing. |
| FG001 | TEST Arm | Subjects assigned to this arm of the study will receive PGS testing. 24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Washington D.C. |
| District of Columbia |
| 20006 |
| United States |
| Florida Fertility Institute/ Women's Medical Research Group, LLC | Clearwater | Florida | 33759 | United States |
| Atlanta Center for Reproductive Medicine | Atlanta | Georgia | 30328 | United States |
| Fertility Centers of Illinois | Chicago | Illinois | 60610 | United States |
| Boston IVF | Boston | Massachusetts | 02451 | United States |
| The Nevada Center for Reproductive Medicine | Reno | Nevada | 89511 | United States |
| Main Line Fertility | Bryn Mawr | Pennsylvania | 19010-3121 | United States |
| Fertility Specialist of Houston | Houston | Texas | 77054 | United States |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CONTROL Arm | Subjects assigned to this arm of the study will receive no PGS testing. |
| BG001 | TEST Arm | Subjects assigned to this arm of the study will receive PGS testing. 24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Implantation Rate | Implantation rate is defined as the ratio between the number of gestational sacs with a fetal heartbeat and the total number of embryos transferred. | Patients who reached embryo transfer were included in this analysis. | Posted | Number | percentage of implantation per group | Data is collected at approximately 4-6 weeks gestation, 20 weeks gestation and 40 weeks gestation. |
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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 | CONTROL Arm | Subjects assigned to this arm of the study will receive no PGS testing. | 0 | 29 | 0 | 29 | ||
| EG001 | TEST Arm | Subjects assigned to this arm of the study will receive PGS testing. 24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS) | 0 | 30 | 0 | 30 |
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Each PI signed an agreement that all data, analyses, information and materials prepared or derived as a direct result of the Study are required to be provided to the sponsor and in accordance with the Protocol, whether preliminary or final (the "Study Results") shall be property of the sponsor. Site may utilize the Study Results for patient care and for it's own internal education purposes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nina Wemmer, MS,CGC, Study Coordinator | Natera (formerly Gene Security Network) | 650-249-9090 | nwemmer@natera.com |
| ID | Term |
|---|---|
| D019836 | Preimplantation Diagnosis |
| ID | Term |
|---|---|
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Male |
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