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| Name | Class |
|---|---|
| Reprogenetics | INDUSTRY |
| Genesis Genetics | OTHER |
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The purpose of the current study is to evaluate the effect of preimplantation genetic screening (PGS) by next generation sequencing (NGS) compared to standard morphological assessment of embryos on pregnancy rates through a randomized controlled trial (RCT). All embryos will be vitrified and a single embryo transfer (SET) will be performed with either screened or unscreened embryos depending on randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Intent to transfer single euploid embryo based on NGS testing (VeriSeq™ PGS) of biopsied blastocysts |
|
| Group B | No Intervention | Intent to transfer single embryo based on morphological assessment according to the Gardner scoring system (no PGS) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preimplantation Genetic Screening by NGS | Other | The VeriSeq PGS takes advantage of next-generation sequencing (NGS) technology to provide comprehensive, accurate screening of all 24 chromosomes for selection of euploid embryos. |
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing Pregnancy | Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation | Gestational Age of 20 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fertility Treatment Center | Tempe | Arizona | 85284 | United States | ||
| HRC Fertility |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23993662 | Result | Handyside AH. 24-chromosome copy number analysis: a comparison of available technologies. Fertil Steril. 2013 Sep;100(3):595-602. doi: 10.1016/j.fertnstert.2013.07.1965. | |
| 23993664 | Result | Schoolcraft WB, Katz-Jaffe MG. Comprehensive chromosome screening of trophectoderm with vitrification facilitates elective single-embryo transfer for infertile women with advanced maternal age. Fertil Steril. 2013 Sep;100(3):615-9. doi: 10.1016/j.fertnstert.2013.07.1972. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Genetic Screening by NGS | Group A: Genetic Screening by NGS (PGT-A) |
| FG001 | Group B: Morphology Only | Group B: Morphology Only (Control) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Encino |
| California |
| 91436 |
| United States |
| Acacio Fertility Clinic | Laguna Niguel | California | 92677 | United States |
| HRC Fertility Pasadena | Pasadena | California | 91105 | United States |
| Fertility Specialists Medical Group | San Diego | California | 92123 | United States |
| Reproductive Science Center of San Francisco Bay Area | San Ramon | California | 94583 | United States |
| Colorado Center for Reproductive Medicine (CCRM) | Lonetree | Colorado | 80125 | United States |
| Reproductive Associates of Delaware | Newark | Delaware | 19713 | United States |
| CRM Orlando | Orlando | Florida | 32804 | United States |
| Georgia Reproductive Specialists | Atlanta | Georgia | 30342 | United States |
| Fertility Institute of Hawaii | Honolulu | Hawaii | 96814 | United States |
| Fertility Center of Illinois, Highland Park | Highland Park | Illinois | 60035 | United States |
| The Advanced IVF Institute | Naperville | Illinois | 60540 | United States |
| IVF New England | Lexington | Massachusetts | 02421 | United States |
| IVF Michigan | Bloomfield Hills | Michigan | 48304 | United States |
| Genesis Genetics (USA) - Genetics Laboratory | Plymouth | Michigan | United States |
| Reproductive Science Center of New Jersey | Eatontown | New Jersey | 07724 | United States |
| Reprogenetics (USA) - Genetics Laboratory | Livingston | New Jersey | 07039 | United States |
| IRMS at St. Barnabas | Livingston | New Jersey | 07078 | United States |
| Main Line Fertility | Bryn Mawr | Pennsylvania | 19010 | United States |
| Texas Fertility Center | Austin | Texas | 78731 | United States |
| Dallas Fertility Center | Dallas | Texas | 75231 | United States |
| Dallas IVF | Frisco | Texas | 75034 | United States |
| Houston Fertility Institute | Houston | Texas | 77063 | United States |
| CORM Houston | Webster | Texas | 77598 | United States |
| Utah Fertility Center | Pleasant Grove | Utah | 84062 | United States |
| Reproductive Care Center | Sandy City | Utah | 84092 | United States |
| Seattle Reproductive Medicine | Seattle | Washington | 98109 | United States |
| Melbourne IVF | Melbourne | Victoria | 3002 | Australia |
| Olive Fertility Centre | Vancouver | British Columbia | V5Z 3X7 | Canada |
| Reproductive Care Center | Mississauga | Ontario | L5N 5S3 | Canada |
| TRIO Fertility Treatment Practice | Toronto | Ontario | M5G 2K4 | Canada |
| Boston Place Clinic | London | Greater London | NW1 6ER | United Kingdom |
| Care Fertility Group London | London | Greater London | NW8 7JL | United Kingdom |
| Care Fertility Group Manchester | Manchester | Greater Manchester | M14 SHQ | United Kingdom |
| Oxford Fertility Unit | Oxford | Oxfordshire | OX42HW | United Kingdom |
| Genesis Genetics (UK) - Genetics Laboratory | London | United Kingdom |
| Reprogenetics (UK) - Genetics Laboratory | Oxford | United Kingdom |
| 22551456 | Result | Yang Z, Liu J, Collins GS, Salem SA, Liu X, Lyle SS, Peck AC, Sills ES, Salem RD. Selection of single blastocysts for fresh transfer via standard morphology assessment alone and with array CGH for good prognosis IVF patients: results from a randomized pilot study. Mol Cytogenet. 2012 May 2;5(1):24. doi: 10.1186/1755-8166-5-24. |
| 24613537 | Result | Fiorentino F, Biricik A, Bono S, Spizzichino L, Cotroneo E, Cottone G, Kokocinski F, Michel CE. Development and validation of a next-generation sequencing-based protocol for 24-chromosome aneuploidy screening of embryos. Fertil Steril. 2014 May;101(5):1375-82. doi: 10.1016/j.fertnstert.2014.01.051. Epub 2014 Mar 6. |
| 24571752 | Result | Bianchi DW, Parker RL, Wentworth J, Madankumar R, Saffer C, Das AF, Craig JA, Chudova DI, Devers PL, Jones KW, Oliver K, Rava RP, Sehnert AJ; CARE Study Group. DNA sequencing versus standard prenatal aneuploidy screening. N Engl J Med. 2014 Feb 27;370(9):799-808. doi: 10.1056/NEJMoa1311037. |
| 31551155 | Result | Munne S, Kaplan B, Frattarelli JL, Child T, Nakhuda G, Shamma FN, Silverberg K, Kalista T, Handyside AH, Katz-Jaffe M, Wells D, Gordon T, Stock-Myer S, Willman S; STAR Study Group. Preimplantation genetic testing for aneuploidy versus morphology as selection criteria for single frozen-thawed embryo transfer in good-prognosis patients: a multicenter randomized clinical trial. Fertil Steril. 2019 Dec;112(6):1071-1079.e7. doi: 10.1016/j.fertnstert.2019.07.1346. Epub 2019 Sep 21. |
| 32898291 | Derived | Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Genetic Screening by NGS | Group A: Genetic Screening by NGS (PGT-A) |
| BG001 | Group B: Morphology Only | Group B: Morphology Only (Control) |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | Ongoing Pregnancy | Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation | Posted | Count of Participants | Participants | Gestational Age of 20 Weeks |
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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 | Group A: Genetic Screening by NGS | Group A: Genetic Screening by NGS (PGT-A) | 0 | 330 | 0 | 330 | ||
| EG001 | Group B: Morphology Only | Group B: Morphology Only (Control) | 0 | 331 | 0 | 331 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tasha Kalista | Illumina | 858-202-4500 | tkalista@illumina.com |
| ID | Term |
|---|---|
| D007246 | Infertility |
| D000782 | Aneuploidy |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D002869 | Chromosome Aberrations |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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| United States |
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| United Kingdom |
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| Australia |
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