Preimplantation Genetic Testing for Aneuploidies in Patients With Recurrent Implantation Failure

Study Overview
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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)

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

Conditions
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Recurrent Implantation Failure

Intervention / Treatment
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* Procedure: PGT-A
* Procedure: Control


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot RCT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PGT-A group<br>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 | Procedure: PGT-A<br>* 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<br>|
| Active Comparator: Control group<br>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. | Procedure: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OPR | Ongoing pregnancy rate per embryo transfer | at 20 weeks gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IR | Implantation rate per transferred embryo | 2 weeks |