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

Primary Purpose

Infertility, Preimplantation Genetic Screening

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Preimplantation Genetic Screening
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ghent University Hospital - Department of Reproductive Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PGS (genetic screening)

no PGS (no genetic screening)

Arm Description

Intent to transfer single cryopreserved embryo, selection based on euploid status (after preimplantation genetic screening) and standard morphological assessment

Intent to transfer single cryopreserved embryo, selection based on standard morphological assessment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Live birth
Rate of live birth (> 24 weeks gestation) after transfer of embryo in PGS arm versus in no PGS arm.
Aneuploidy
Rate of aneuploid versus rate of euploid embryos in PGS arm.

Full Information

First Posted
May 19, 2017
Last Updated
March 31, 2020
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT03173885
Brief Title
Investigating the Cryopreserved Blastocyst's ImplantatiOn Potential After Genetic Screening
Acronym
BIOPS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Due to the slow recruitment of patients
Study Start Date
May 18, 2017 (Actual)
Primary Completion Date
February 5, 2020 (Actual)
Study Completion Date
February 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Preimplantation Genetic Screening

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT (randomized controlled trial)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PGS (genetic screening)
Arm Type
Experimental
Arm Description
Intent to transfer single cryopreserved embryo, selection based on euploid status (after preimplantation genetic screening) and standard morphological assessment
Arm Title
no PGS (no genetic screening)
Arm Type
No Intervention
Arm Description
Intent to transfer single cryopreserved embryo, selection based on standard morphological assessment
Intervention Type
Diagnostic Test
Intervention Name(s)
Preimplantation Genetic Screening
Intervention Description
laser assisted hatching trophectoderm biopsy next generation sequencing
Primary Outcome Measure Information:
Title
Clinical pregnancy
Description
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.
Time Frame
At 7 - 8 gestational weeks
Secondary Outcome Measure Information:
Title
Biochemical pregnancy
Description
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.
Time Frame
At 7 -8 gestational weeks
Title
Clinical miscarriage
Description
Rate of clinical miscarriage (intrauterine pregnancy demise confirmed by ultrasound or histology) after transfer of embryo in PGS arm versus in no PGS arm.
Time Frame
At 7 - 16 gestational weeks
Title
Live birth
Description
Rate of live birth (> 24 weeks gestation) after transfer of embryo in PGS arm versus in no PGS arm.
Time Frame
At delivery
Title
Aneuploidy
Description
Rate of aneuploid versus rate of euploid embryos in PGS arm.
Time Frame
At delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra De Sutter, M.D; PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital - Department of Reproductive Medicine
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
32898291
Citation
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.
Results Reference
derived

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Investigating the Cryopreserved Blastocyst's ImplantatiOn Potential After Genetic Screening

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