Actively Recruiting
Preimplantation Genetic Testing for Aneuploidies (PGT-A) in Patients With Recurrent Implantation Failure: a Pilot Randomized Controlled Trial
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-02-26
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether Preimplantation Genetic Testing for Aneuploidy (PGT-A) can improve pregnancy outcomes in women experiencing Recurrent Implantation Failure (RIF). The study aims to determine if PGT-A increases the ongoing pregnancy rate per transferred embryo, reduces the time to pregnancy, and lowers miscarriage rates in this group of patients. Participants are randomly assigned to one of two groups. The first group undergoes ovarian stimulation, egg retrieval, embryo culture to the blastocyst stage, trophectoderm biopsy, freezing of all blastocyst embryos, PGT-A using next-generation sequencing, and transfer of genetically normal embryos in frozen-thawed cycles. The control group undergoes ovarian stimulation, egg retrieval, embryo culture to blastocyst stage, fresh transfer of the best-appearing embryo, freezing of extra embryos, and frozen-thawed embryo transfers if pregnancy is not achieved in the fresh cycle. Women in the study will be monitored through pregnancy to assess the ongoing pregnancy rate at 20 weeks gestation and implantation rate at 2 weeks. The study involves multiple embryo transfer cycles as needed, with evaluation of pregnancy outcomes and safety. Participation includes visits for ovarian stimulation, egg retrieval, embryo culture, biopsies, embryo transfers, and follow-up until pregnancy confirmation or conclusion of treatment cycles.
CONDITIONS
Brief Title
Preimplantation Genetic Testing for Aneuploidies in Patients With Recurrent Implantation Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with recurrent implantation failure (previous transfer of least 4 good quality embryos in at least 3 fresh or frozen cycles)
- Body mass index (BMI) less than 35
- Normal hysteroscopy exam
- Female gender
- Age between 18 and 40 years
You will not qualify if you...
- Thin endometrium in previous cycles (less than 6mm)
- Endometriosis with ASRM score III-IV
- Premature ovarian failure defined by Bologna criteria
- Abnormal karyotype
- Use of donor oocytes or embryos
- Preimplantation Genetic Testing for Monogenic disorders (PGT-M)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of ovarian stimulation and embryo transfer cycles as per protocol
Participants undergo ovarian stimulation, oocyte aspiration, and embryo culture until the blastocyst stage (day 5/6). Depending on the group, embryo transfer occurs either after genetic testing of embryos or fresh transfer of the best embryo, followed by cumulative frozen-thawed embryo transfer cycles if needed.
Multiple visits during stimulation, aspiration, and embryo transfer cycles
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
M
Myriam Welkenhuysen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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