Preimplantation Genetic Testing for Aneuploidies in Patients With Recurrent Implantation Failure

Not Applicable

Recruiting

• Conditions: Recurrent Implantation Failure
• Interventions: Procedure: Control; Procedure: PGT-A

• Registration Number: NCT03900780
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-03
• Study Start: 2019-05-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	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.
PGT-A group	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

Primary Outcome Measures

Name	Time	Method
OPR	at 20 weeks gestational age	Ongoing pregnancy rate per embryo transfer

Secondary Outcome Measures

Name	Time	Method
IR	2 weeks	Implantation rate per transferred embryo

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium