NCT03173885

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 19, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2020

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.7 years

First QC Date

May 19, 2017

Last Update Submit

September 5, 2024

Conditions

InfertilityPreimplantation Genetic Screening

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Biochemical pregnancy

    At 7 -8 gestational weeks

  • Clinical miscarriage

    At 7 - 16 gestational weeks

  • Live birth

    At delivery

  • Aneuploidy

    At delivery

Study Arms (2)

PGS (genetic screening)

EXPERIMENTAL

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

Diagnostic Test: Preimplantation Genetic Screening

no PGS (no genetic screening)

NO INTERVENTION

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

Interventions

Preimplantation Genetic ScreeningDIAGNOSTIC_TEST

* laser assisted hatching * trophectoderm biopsy * next generation sequencing

PGS (genetic screening)

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital - Department of Reproductive Medicine

Ghent, 9000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 32898291DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Preimplantation Diagnosis

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Petra De Sutter, M.D; PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT (randomized controlled trial)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2017

First Posted

June 2, 2017

Study Start

May 18, 2017

Primary Completion

February 5, 2020

Study Completion

February 5, 2020

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)