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Preimplantation Genetic Testing for Aneuploidies in Patients With Recurrent Implantation Failure

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03900780
Enrollment
100
Registered
2019-04-03
Start date
2019-05-01
Completion date
2026-12-31
Last updated
2025-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Implantation Failure

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)

Interventions

PROCEDUREPGT-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

PROCEDUREControl

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.

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Pilot RCT

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
OPRat 20 weeks gestational ageOngoing pregnancy rate per embryo transfer

Secondary

MeasureTime frameDescription
IR2 weeksImplantation rate per transferred embryo

Countries

Belgium

Contacts

Primary ContactMyriam Welkenhuysen
myriam.welkenhuysen@uzleuven.be+3216343544

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026