STAR: Single Embryo TrAnsfeR of Euploid Embryo

• Sponsor: Illumina, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02268786
• Collaborator: Reprogenetics (Industry), Genesis Genetics (Other)
• Enrollment: 661
• Locations: 38
• Arms: 2
• Actual Duration (Months): 28
• Patients Per Site: 17.4
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infertility; Aneuploidy	Other: Preimplantation Genetic Screening by NGS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 661 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Screening
• 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
• Actual Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Dec 31, 2016
• Actual Study Completion Date: Dec 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A Intent to transfer single euploid embryo based on NGS testing (VeriSeq™ PGS) of biopsied blastocysts	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.; Other Names: Veriseq PGS
No Intervention: Group B Intent to transfer single embryo based on morphological assessment according to the Gardner scoring system (no PGS)

Outcome Measures

Primary Outcome Measures

1. Ongoing Pregnancy [Gestational Age of 20 Weeks]

   Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fertility Treatment Center	Tempe	Arizona	United States	85284
2	HRC Fertility	Encino	California	United States	91436
3	Acacio Fertility Clinic	Laguna Niguel	California	United States	92677
4	HRC Fertility Pasadena	Pasadena	California	United States	91105
5	Fertility Specialists Medical Group	San Diego	California	United States	92123
6	Reproductive Science Center of San Francisco Bay Area	San Ramon	California	United States	94583
7	Colorado Center for Reproductive Medicine (CCRM)	Lonetree	Colorado	United States	80125
8	Reproductive Associates of Delaware	Newark	Delaware	United States	19713
9	CRM Orlando	Orlando	Florida	United States	32804
10	Georgia Reproductive Specialists	Atlanta	Georgia	United States	30342
11	Fertility Institute of Hawaii	Honolulu	Hawaii	United States	96814
12	Fertility Center of Illinois, Highland Park	Highland Park	Illinois	United States	60035
13	The Advanced IVF Institute	Naperville	Illinois	United States	60540
14	IVF New England	Lexington	Massachusetts	United States	02421
15	IVF Michigan	Bloomfield Hills	Michigan	United States	48304
16	Genesis Genetics (USA) - Genetics Laboratory	Plymouth	Michigan	United States
17	Reproductive Science Center of New Jersey	Eatontown	New Jersey	United States	07724
18	Reprogenetics (USA) - Genetics Laboratory	Livingston	New Jersey	United States	07039
19	IRMS at St. Barnabas	Livingston	New Jersey	United States	07078
20	Main Line Fertility	Bryn Mawr	Pennsylvania	United States	19010
21	Texas Fertility Center	Austin	Texas	United States	78731
22	Dallas Fertility Center	Dallas	Texas	United States	75231
23	Dallas IVF	Frisco	Texas	United States	75034
24	Houston Fertility Institute	Houston	Texas	United States	77063
25	CORM Houston	Webster	Texas	United States	77598
26	Utah Fertility Center	Pleasant Grove	Utah	United States	84062
27	Reproductive Care Center	Sandy	Utah	United States	84092
28	Seattle Reproductive Medicine	Seattle	Washington	United States	98109
29	Melbourne IVF	Melbourne	Victoria	Australia	3002
30	Olive Fertility Centre	Vancouver	British Columbia	Canada	V5Z 3X7
31	Reproductive Care Center	Mississauga	Ontario	Canada	L5N 5S3
32	TRIO Fertility Treatment Practice	Toronto	Ontario	Canada	M5G 2K4
33	Boston Place Clinic	London	Greater London	United Kingdom	NW1 6ER
34	Care Fertility Group London	London	Greater London	United Kingdom	NW8 7JL
35	Care Fertility Group Manchester	Manchester	Greater Manchester	United Kingdom	M14 SHQ
36	Oxford Fertility Unit	Oxford	Oxfordshire	United Kingdom	OX42HW
37	Genesis Genetics (UK) - Genetics Laboratory	London		United Kingdom
38	Reprogenetics (UK) - Genetics Laboratory	Oxford		United Kingdom

Sponsors and Collaborators

• Illumina, Inc.
• Reprogenetics
• Genesis Genetics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Illumina, Inc.
• ClinicalTrials.gov Identifier: NCT02268786
• Other Study ID Numbers: RGH-001
• First Posted: Oct 20, 2014
• Last Update Posted: May 13, 2020
• Last Verified: May 1, 2020

• Keywords provided by Illumina, Inc.: Preimplantation Genetic Screening; Blastocyst; Vitrification; In vitro fertilization; non-invasive prenatal testing; next generation sequencing
• Additional relevant MeSH terms: Infertility; Aneuploidy

Study Results

Participant Flow

Arm/Group Title	Group A: Genetic Screening by NGS	Group B: Morphology Only
Arm/Group Description	Group A: Genetic Screening by NGS (PGT-A)	Group B: Morphology Only (Control)
Period Title: Overall Study
STARTED	330	331
COMPLETED	274	313
NOT COMPLETED	56	18

Baseline Characteristics

Arm/Group Title	Group A: Genetic Screening by NGS	Group B: Morphology Only	Total
Arm/Group Description	Group A: Genetic Screening by NGS (PGT-A)	Group B: Morphology Only (Control)	Total of all reporting groups
Overall Participants	330	331	661
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	330 100%	331 100%	661 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.7 (3.59)	33.8 (3.58)	33.7 (3.58)
Sex: Female, Male (Count of Participants)
Female	330 100%	331 100%	661 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Canada	42 12.7%	32 9.7%	74 11.2%
United States	244 73.9%	244 73.7%	488 73.8%
United Kingdom	34 10.3%	43 13%	77 11.6%
Australia	10 3%	12 3.6%	22 3.3%

Outcome Measures

1. Primary Outcome

Title	Ongoing Pregnancy
Description	Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation
Time Frame	Gestational Age of 20 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A: Genetic Screening by NGS	Group B: Morphology Only
Arm/Group Description	Group A: Genetic Screening by NGS (PGT-A)	Group B: Morphology Only (Control)
Measure Participants	274	313
Count of Participants [Participants]	137 41.5%	143 43.2%

Adverse Events

Arm/Group Title	Group A: Genetic Screening by NGS		Group B: Morphology Only
Arm/Group Description	Group A: Genetic Screening by NGS (PGT-A)		Group B: Morphology Only (Control)
All Cause Mortality
	Group A: Genetic Screening by NGS		Group B: Morphology Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Group A: Genetic Screening by NGS		Group B: Morphology Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/330 (0%)		0/331 (0%)
Other (Not Including Serious) Adverse Events
	Group A: Genetic Screening by NGS		Group B: Morphology Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/330 (0%)		0/331 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.