Clinical trial NCT03173885: Investigating the Cryopreserved Blastocyst's ImplantatiOn Potential After Genetic Screening
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Preimplantation Genetic Screening
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2017-06-02
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT (randomized controlled trial)
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Clinical pregnancy
timeFrame: At 7 - 8 gestational weeks
Secondary outcomes:
measure: Biochemical pregnancy
timeFrame: At 7 -8 gestational weeks
measure: Clinical miscarriage
timeFrame: At 7 - 16 gestational weeks
measure: Live birth
timeFrame: At delivery
measure: Aneuploidy
timeFrame: At delivery
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital - Department of Reproductive Medicine
Study officials:
affiliation: University Hospital, Ghent
name: Petra De Sutter, M.D; PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3.