Preimplantation Genetic Testing for Aneuploidies in Patients With Recurrent Implantation Failure

NCT ID: NCT03900780

Last Updated: 2025-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Recurrent Implantation Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pilot RCT
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

PGT-A

Intervention Type PROCEDURE

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 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.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type PROCEDURE

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.

Interventions

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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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Brecht Geysenbergh

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Myriam Welkenhuysen

Role: CONTACT

+3216343544

Facility Contacts

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Myriam Welkenhuysen

Role: primary

+3216343544

Brecht Geysenbergh, MD

Role: backup

+32496125137

Other Identifiers

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S62302

Identifier Type: -

Identifier Source: org_study_id

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