Single Embryo TrAnsfeR of Euploid Embryo

Brief Title

Single Embryo TrAnsfeR of Euploid Embryo

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

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.
    



Study Type

Interventional


Primary Outcome

Ongoing Pregnancy


Condition

Infertility

Intervention

Preimplantation Genetic Screening by NGS

Study Arms / Comparison Groups

 Group A
Description:  Intent to transfer single euploid embryo based on NGS testing (VeriSeq™ PGS) of biopsied blastocysts

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

661

Start Date

September 2014

Completion Date

December 31, 2016

Primary Completion Date

December 31, 2016

Eligibility Criteria

        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
      

Gender

Female

Ages

25 Years - 40 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT02268786

Organization ID

RGH-001


Responsible Party

Sponsor

Study Sponsor

Illumina, Inc.

Collaborators

 Reprogenetics

Study Sponsor

, , 


Verification Date

May 2020