Investigating the Cryopreserved Blastocyst's ImplantatiOn Potential After Genetic Screening

Study Overview
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Brief Summary
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This is a two-arm parallel group randomized controlled trial at the Department of Reproductive Medicine at Ghent University Hospital. Women >=18 and <37 years of age undergoing their first or second IVF/ICSI treatment, with at least 2 good quality blastocysts remaining after fresh embryo transfer will be randomized to either transfer of a cryopreserved blastocyst selected based on morphology (standard treatment arm) or transfer of a cryopreserved blastocyst selected based on PGS and morphology (intervention treatment arm).

Official Title
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An RCT Evaluating the Implantation Potential of Vitrified Embryos Screened by Next Generation Sequencing Following Trophectoderm Biopsy, Versus Vitrified Unscreened Embryos in Good Prognosis Patients Undergoing IVF

Conditions
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Infertility, Preimplantation Genetic Screening

Intervention / Treatment
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* Diagnostic Test: Preimplantation Genetic Screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 2 blastocysts suitable for biopsy on day 5 of embryo development remaining after fresh transfer willing and able to give informed consent infertility as an indication for IVF/ICSI first or second IVF/ICSI cycle patients willing to accept single embryo transfer BMI range 18 to 35 kg/m2 Exclusion Criteria: any type of genetic abnormality or family history of genetic abnormality in subject or partner any other non-study related preimplantation genetic testing three or more clinical miscarriages (recurrent pregnancy loss, RPL) recurrent implantation failure (RIF): no positive β-hCG after transfer (fresh IVF/ICSI cycle or frozen) with no less than 6 cleavage stage embryos or no less than 4 blastocysts, all of good quality and of appropriate developmental stage severe endometriosis abnormal uterine cavity cycles requiring surgical sperm recovery procedures, total asthenozoospermia and/or globozoospermia treatment involving use of donor oocytes or use of gestational carrier

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 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: RCT (randomized controlled trial)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PGS (genetic screening)<br>Intent to transfer single cryopreserved embryo, selection based on euploid status (after preimplantation genetic screening) and standard morphological assessment | Diagnostic Test: Preimplantation Genetic Screening<br>* laser assisted hatching trophectoderm biopsy next generation sequencing<br>|
| No Intervention: no PGS (no genetic screening)<br>Intent to transfer single cryopreserved embryo, selection based on standard morphological assessment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy | Rate of clinical pregnancy (a pregnancy diagnosed by ultrasonic visualisation of one or more gestational sacs with fetal heart beat) after transfer of embryo in PGS arm versus in no PGS arm. | At 7 - 8 gestational weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical pregnancy | Rate of biochemical pregnancy (a pregnancy diagnosed only by either serum or urine β-hCG, and the serial results decrease to negative; no ultrasonic visualisation of one or more gestational sacs) after transfer of embryo in PGS arm versus in no PGS arm. | At 7 -8 gestational weeks | 
| Clinical miscarriage | Rate of clinical miscarriage (intrauterine pregnancy demise confirmed by ultrasound or histology) after transfer of embryo in PGS arm versus in no PGS arm. | At 7 - 16 gestational weeks | 
| Live birth | Rate of live birth (> 24 weeks gestation) after transfer of embryo in PGS arm versus in no PGS arm. | At delivery | 
| Aneuploidy | Rate of aneuploid versus rate of euploid embryos in PGS arm. | At delivery |