- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03900780
Preimplantation Genetic Testing for Aneuploidies in Patients With Recurrent Implantation Failure
September 29, 2021 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 (Anticipated)
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 Locations
-
-
-
Leuven, Belgium, 3000
- Recruiting
- UZ Leuven
-
-
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
Genders Eligible for Study
Female
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
- Masking: NONE
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
|
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.
|
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.
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 (ANTICIPATED)
December 1, 2022
Study Completion (ANTICIPATED)
December 1, 2023
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)
October 7, 2021
Last Update Submitted That Met QC Criteria
September 29, 2021
Last Verified
September 1, 2021
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.
Clinical Trials on Recurrent Implantation Failure
-
Mehdi YousefiCompletedRecurrent Implantation FailureIran, Islamic Republic of
-
Kasr El Aini HospitalUnknownRecurrent Implantation Failure
-
Dr. Kamal RagehCompleted
-
SCARM Institute, Tabriz, IranCompleted
-
Tabriz University of Medical SciencesCompletedRecurrent Implantation FailureIran, Islamic Republic of
-
Shanghai First Maternity and Infant HospitalUnknownRecurrent Implantation FailureChina
-
Al Baraka Fertility HospitalRecruiting
-
Assistance Publique - Hôpitaux de ParisRecruitingRecurrent Unexplained Implantation FailureFrance
-
TopLab Company for ART Laboratories Consultation...CompletedRecurrent Implantation Failure (RIF)
-
ShangHai Ji Ai Genetics & IVF InstituteRecruitingAcupuncture | Recurrent Implantation FailureChina
Clinical Trials on PGT-A
-
Kaohsiung Veterans General Hospital.Sofiva Genomics Co., Ltd.Recruiting
-
ART Fertility Clinics LLCCompleted
-
IgenomixCompletedAneuploidy | Chromosome AbnormalityItaly
-
Eyup Hakan DuranRecruiting
-
Rigshospitalet, DenmarkNot yet recruitingInfertilityDenmark
-
IgenomixCompletedInfertility | Aneuploidy | Chromosome AbnormalityMexico, Turkey, United States, Argentina, Spain, Brazil, Italy, Peru
-
ART Fertility Clinics LLCWithdrawn
-
King's College LondonGuy's and St Thomas' NHS Foundation TrustRecruiting
-
IgenomixTerminatedInfertility of Uterine OriginUnited States, Argentina, Brazil, Canada, Chile, Georgia, India, Mexico, Spain, Taiwan, Turkey, Vietnam
-
Clinica de la Mujer Medicina Reproductiva, ChileCompleted