Infertility Clinical Trial
— STAROfficial title:
Prospective, Multi-center, Randomized Controlled Trial Comparing Pregnancy Outcomes Following Selection and Single Embryo Transfer (SET) Based on Preimplantation Genetic Screening (PGS) by Next Generation Sequencing (NGS) Versus Standard Morphological Assessment
Verified date | May 2020 |
Source | Illumina, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 661 |
Est. completion date | December 31, 2016 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Patient undergoing IVF - At least 2 blastocysts suitable for biopsy on day 5 or 6 of embryo development Exclusion Criteria: - History of more than two prior implantation failure following IVF - History of more than one miscarriage of viable pregnancy - One or both partners known to be carrier(s) of a chromosomal abnormality - Known genetic carrier couple and/or one or both partners carrier of a known autosomal dominant disorder - Any other non-study related preimplantation genetic testing - Use of donor oocytes - Use of gestational carrier (surrogate or donor egg recipient). - Severe oligospermia (<1,000,000 sperm/ml); Surgical Sperm Retrieval for reasons other than post-vasectomy and CAVD - Low ovarian reserve with (FSH) >10 IU/L on day 2-4 of a prior menstrual cycle and/or (AMH) <7 pmol/L (or <1 ng/ml) - Gender selection cycles - Concurrent participation in another clinical trial |
Country | Name | City | State |
---|---|---|---|
Australia | Melbourne IVF | Melbourne | Victoria |
Canada | Reproductive Care Center | Mississauga | Ontario |
Canada | TRIO Fertility Treatment Practice | Toronto | Ontario |
Canada | Olive Fertility Centre | Vancouver | British Columbia |
United Kingdom | Boston Place Clinic | London | Greater London |
United Kingdom | Care Fertility Group London | London | Greater London |
United Kingdom | Genesis Genetics (UK) - Genetics Laboratory | London | |
United Kingdom | Care Fertility Group Manchester | Manchester | Greater Manchester |
United Kingdom | Oxford Fertility Unit | Oxford | Oxfordshire |
United Kingdom | Reprogenetics (UK) - Genetics Laboratory | Oxford | |
United States | Georgia Reproductive Specialists | Atlanta | Georgia |
United States | Texas Fertility Center | Austin | Texas |
United States | IVF Michigan | Bloomfield Hills | Michigan |
United States | Main Line Fertility | Bryn Mawr | Pennsylvania |
United States | Dallas Fertility Center | Dallas | Texas |
United States | Reproductive Science Center of New Jersey | Eatontown | New Jersey |
United States | HRC Fertility | Encino | California |
United States | Dallas IVF | Frisco | Texas |
United States | Fertility Center of Illinois, Highland Park | Highland Park | Illinois |
United States | Fertility Institute of Hawaii | Honolulu | Hawaii |
United States | Houston Fertility Institute | Houston | Texas |
United States | Acacio Fertility Clinic | Laguna Niguel | California |
United States | IVF New England | Lexington | Massachusetts |
United States | IRMS at St. Barnabas | Livingston | New Jersey |
United States | Reprogenetics (USA) - Genetics Laboratory | Livingston | New Jersey |
United States | Colorado Center for Reproductive Medicine (CCRM) | Lonetree | Colorado |
United States | The Advanced IVF Institute | Naperville | Illinois |
United States | Reproductive Associates of Delaware | Newark | Delaware |
United States | CRM Orlando | Orlando | Florida |
United States | HRC Fertility Pasadena | Pasadena | California |
United States | Utah Fertility Center | Pleasant Grove | Utah |
United States | Genesis Genetics (USA) - Genetics Laboratory | Plymouth | Michigan |
United States | Fertility Specialists Medical Group | San Diego | California |
United States | Reproductive Science Center of San Francisco Bay Area | San Ramon | California |
United States | Reproductive Care Center | Sandy | Utah |
United States | Seattle Reproductive Medicine | Seattle | Washington |
United States | Fertility Treatment Center | Tempe | Arizona |
United States | CORM Houston | Webster | Texas |
Lead Sponsor | Collaborator |
---|---|
Illumina, Inc. | Genesis Genetics, Reprogenetics |
United States, Australia, Canada, United Kingdom,
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): — View Citation
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):137 — View Citation
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. Review. — View Citation
Munné 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 select — View Citation
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.fertnste — View Citation
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 pil — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ongoing Pregnancy | Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation | Gestational Age of 20 Weeks |
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