Single Embryo TrAnsfeR of Euploid Embryo

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Infertility, Aneuploidy

Intervention / Treatment
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* Other: Preimplantation Genetic Screening by NGS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Intent to transfer single euploid embryo based on NGS testing (VeriSeq™ PGS) of biopsied blastocysts | Other: Preimplantation Genetic Screening by NGS<br>* 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.<br>* Other names: Veriseq PGS;|
| No Intervention: Group B<br>Intent to transfer single embryo based on morphological assessment according to the Gardner scoring system (no PGS) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing Pregnancy | Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation | Gestational Age of 20 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preimplantation Genetic Screening, Blastocyst, Vitrification, In vitro fertilization, non-invasive prenatal testing, next generation sequencing