Preimplantation Genetic Testing for Aneuploidies in Patients With Recurrent Implantation Failure

February 25, 2025 updated by: Brecht Geysenbergh, Universitaire Ziekenhuizen KU Leuven

Preimplantion Genetic Testing for Aneuploidies (PGT-A) in Patients With Recurrent Implantation Failure: a Pilot RCT

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OPR
Time Frame: at 20 weeks gestational age
Ongoing pregnancy rate per embryo transfer
at 20 weeks gestational age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IR
Time Frame: 2 weeks
Implantation rate per transferred embryo
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 3, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S62302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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