Investigating the Cryopreserved Blastocyst's ImplantatiOn Potential After Genetic Screening

University Hospital, Ghent56 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infertility Preimplantation Genetic Screening

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 37 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: At 7 - 8 gestational weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: At delivery

Aneuploidy

Rate of aneuploid versus rate of euploid embryos in PGS arm.