Infertility, Preimplantation Genetic Screening
Conditions
Brief summary
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).
Interventions
DIAGNOSTIC_TESTPreimplantation Genetic Screening
* laser assisted hatching * trophectoderm biopsy * next generation sequencing
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
RCT (randomized controlled trial)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy | At 7 - 8 gestational weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical pregnancy | At 7 -8 gestational weeks | 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. |
| Clinical miscarriage | At 7 - 16 gestational weeks | Rate of clinical miscarriage (intrauterine pregnancy demise confirmed by ultrasound or histology) after transfer of embryo in PGS arm versus in no PGS arm. |
| Live birth | At delivery | Rate of live birth (\> 24 weeks gestation) after transfer of embryo in PGS arm versus in no PGS arm. |
| Aneuploidy | At delivery | Rate of aneuploid versus rate of euploid embryos in PGS arm. |
Countries
Belgium
Outcome results
None listed