Preimplantation Genetic Testing for Aneuploidies in Patients With Recurrent Implantation Failure

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • PGT-A

    Procedure/Surgery

    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

  • Control

    Procedure/Surgery

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: PGT-A groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

OPR

Ongoing pregnancy rate per embryo transfer

Time frame
at 20 weeks gestational age

Secondary outcomes

1

IR

Implantation rate per transferred embryo

Time frame
2 weeks

Other outcomes

Sponsors and contacts

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