Single Embryo TrAnsfeR of Euploid Embryo

Infertility Clinical Trial

— STAR  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268786
• Other study ID #: RGH-001
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: May 2020
• Source: Illumina, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aneuploidy
• Infertility

Intervention

Other:
• Preimplantation Genetic Screening by NGS
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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Illumina, Inc.	Genesis Genetics, Reprogenetics

Countries where clinical trial is conducted

United States,  Australia,  Canada,  United Kingdom, 

References & Publications (6)

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

Outcome

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