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Preimplantation Genetic Testing for Aneuploidies in Patients With Recurrent Implantation Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03900780
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : October 7, 2021
Sponsor:
Information provided by (Responsible Party):
Brecht Geysenbergh, Universitaire Ziekenhuizen Leuven

Study Description
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Brief Summary:
Assessing whether Preimplantation Genetic Testing for Aneuploidy (PGT-A) can increase the ongoing pregnancy rate per transferred embryo and can decrease the time to pregnancy and miscarriage rate in patients with Recurrent Implantation Failure (RIF)

Condition or disease Intervention/treatment Phase
Recurrent Implantation Failure Procedure: PGT-A Procedure: Control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot RCT
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preimplantion Genetic Testing for Aneuploidies (PGT-A) in Patients With Recurrent Implantation Failure: a Pilot RCT
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

Arms and Interventions
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Arm Intervention/treatment
Experimental: PGT-A group
ovarian stimulation, oocyte aspiration, embryo culture until the blastocyst stage (day 5/6), TE biopsy, vitrification of all embryos in the blastocyst stage, PGT-A by NGS and finally embryo transfer of genetically normal embryos in cumulative frozen-thawed embryo transfer cycles
 Procedure: PGT-A
ovarian stimulation, oocyte aspiration, embryo culture until the blastocyst stage (day 5/6), TE biopsy, vitrification of all embryos in the blastocyst stage, PGT-A by NGS and finally embryo transfer of genetically normal embryos in cumulative frozen-thawed embryo transfer cycles
Active Comparator: Control group
ovarian stimulation, oocyte aspiration, embryo culture until the blastocyst stage, fresh embryo transfer of the morphologically best embryo on day 5/6, vitrification of supernumerary embryos and embryo transfer in cumulative frozen-thawed embryo transfer cycles if not pregnant from the fresh cycle.
 Procedure: Control
ovarian stimulation, oocyte aspiration, embryo culture until the blastocyst stage, fresh embryo transfer of the morphologically best embryo on day 5/6, vitrification of supernumerary embryos and embryo transfer in cumulative frozen-thawed embryo transfer cycles if not pregnant from the fresh cycle.


Outcome Measures
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Primary Outcome Measures :
  1. OPR [ Time Frame: at 20 weeks gestational age ]
    Ongoing pregnancy rate per embryo transfer


Secondary Outcome Measures :
  1. IR [ Time Frame: 2 weeks ]
    Implantation rate per transferred embryo


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with recurrent implantation failure (previous transfer of least 4 good quality embryos in at least 3 fresh or frozen cycles)
  • BMI < 35
  • Normal hysteroscopy

Exclusion Criteria:

  • thin endometrium in previous cycles (<6mm), endometriosis ASRM score III-IV, premature ovarian failure (POF, Bologna criteria), abnormal karyotype, donor oocytes or embryos, PGT-M
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900780


Contacts
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Contact: Myriam Welkenhuysen +3216343544 myriam.welkenhuysen@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Myriam Welkenhuysen    +3216343544    myriam.welkenhuysen@uzleuven.be   
Contact: Brecht Geysenbergh, MD    +32496125137    brecht.geysenbergh@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
More Information
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Responsible Party: Brecht Geysenbergh, Principal Investigator, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03900780    
Other Study ID Numbers: S62302
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneuploidy
Chromosome Aberrations
Pathologic Processes