Aneuploidy, Infertility
Conditions
Keywords
Preimplantation Genetic Screening, Blastocyst, Vitrification, In vitro fertilization, non-invasive prenatal testing, next generation sequencing
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.
Interventions
OTHERPreimplantation 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.
Sponsors
Reprogenetics
Genesis Genetics
Illumina, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing Pregnancy | Gestational Age of 20 Weeks | Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation |
Countries
Australia, Canada, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A: Genetic Screening by NGS Group A: Genetic Screening by NGS (PGT-A) | 330 |
| Group B: Morphology Only Group B: Morphology Only (Control) | 331 |
| Total | 661 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | No Euploid Embryos available | 42 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Thaw Failure | 6 | 4 |
| Overall Study | Withdrawal by Subject | 7 | 14 |
Baseline characteristics
| Characteristic | Group A: Genetic Screening by NGS | Group B: Morphology Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 330 Participants | 331 Participants | 661 Participants |
| Age, Continuous | 33.7 years STANDARD_DEVIATION 3.59 | 33.8 years STANDARD_DEVIATION 3.58 | 33.7 years STANDARD_DEVIATION 3.58 |
| Region of Enrollment Australia | 10 participants | 12 participants | 22 participants |
| Region of Enrollment Canada | 42 participants | 32 participants | 74 participants |
| Region of Enrollment United Kingdom | 34 participants | 43 participants | 77 participants |
| Region of Enrollment United States | 244 participants | 244 participants | 488 participants |
| Sex: Female, Male Female | 330 Participants | 331 Participants | 661 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 330 | 0 / 331 |
| serious Total, serious adverse events | 0 / 330 | 0 / 331 |
Outcome results
Primary
Ongoing Pregnancy
Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation
Time frame: Gestational Age of 20 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A: Genetic Screening by NGS | Ongoing Pregnancy | 137 Participants |
| Group B: Morphology Only | Ongoing Pregnancy | 143 Participants |