Investigating the Cryopreserved Blastocyst's ImplantatiOn Potential After Genetic Screening (BIOPS)

An RCT Evaluating the Implantation Potential of Vitrified Embryos Screened by Next Generation Sequencing Following Trophectoderm Biopsy, Versus Vitrified Unscreened Embryos in Good Prognosis Patients Undergoing IVF

This is a two-arm parallel group randomized controlled trial at the Department of Reproductive Medicine at Ghent University Hospital. Women >=18 and <37 years of age undergoing their first or second IVF/ICSI treatment, with at least 2 good quality blastocysts remaining after fresh embryo transfer will be randomized to either transfer of a cryopreserved blastocyst selected based on morphology (standard treatment arm) or transfer of a cryopreserved blastocyst selected based on PGS and morphology (intervention treatment arm).

Study Overview

• Status: Terminated
• Conditions: Infertility; Preimplantation Genetic Screening
• Intervention / Treatment: Diagnostic test: Preimplantation Genetic Screening

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital - Department of Reproductive Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 37 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• at least 2 blastocysts suitable for biopsy on day 5 of embryo development remaining after fresh transfer
• willing and able to give informed consent
• infertility as an indication for IVF/ICSI
• first or second IVF/ICSI cycle
• patients willing to accept single embryo transfer
• BMI range 18 to 35 kg/m2

Exclusion Criteria:

• any type of genetic abnormality or family history of genetic abnormality in subject or partner
• any other non-study related preimplantation genetic testing
• three or more clinical miscarriages (recurrent pregnancy loss, RPL)
• recurrent implantation failure (RIF): no positive β-hCG after transfer (fresh IVF/ICSI cycle or frozen) with no less than 6 cleavage stage embryos or no less than 4 blastocysts, all of good quality and of appropriate developmental stage
• severe endometriosis
• abnormal uterine cavity
• cycles requiring surgical sperm recovery procedures, total asthenozoospermia and/or globozoospermia
• treatment involving use of donor oocytes or use of gestational carrier

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PGS (genetic screening); Intent to transfer single cryopreserved embryo, selection based on euploid status (after preimplantation genetic screening) and standard morphological assessment	Diagnostic test: Preimplantation Genetic Screening; laser assisted hatching; trophectoderm biopsy; next generation sequencing
No Intervention: no PGS (no genetic screening); Intent to transfer single cryopreserved embryo, selection based on standard morphological assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy	Rate of clinical pregnancy (a pregnancy diagnosed by ultrasonic visualisation of one or more gestational sacs with fetal heart beat) after transfer of embryo in PGS arm versus in no PGS arm.	At 7 - 8 gestational weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical pregnancy	Rate of biochemical pregnancy (a pregnancy diagnosed only by either serum or urine β-hCG, and the serial results decrease to negative; no ultrasonic visualisation of one or more gestational sacs) after transfer of embryo in PGS arm versus in no PGS arm.	At 7 -8 gestational weeks
Clinical miscarriage	Rate of clinical miscarriage (intrauterine pregnancy demise confirmed by ultrasound or histology) after transfer of embryo in PGS arm versus in no PGS arm.	At 7 - 16 gestational weeks
Live birth	Rate of live birth (> 24 weeks gestation) after transfer of embryo in PGS arm versus in no PGS arm.	At delivery
Aneuploidy	Rate of aneuploid versus rate of euploid embryos in PGS arm.	At delivery

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Petra De Sutter, M.D; PhD, University Hospital, Ghent

Publications and helpful links

General Publications

• Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2017
• Primary Completion (Actual): February 5, 2020
• Study Completion (Actual): February 5, 2020

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: B670201629937; 2016/1235 (Other Identifier: Ghent University Hospital)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No