Investigating the Cryopreserved Blastocyst's ImplantatiOn Potential After Genetic Screening (BIOPS)

Ghent University Hospital (UZ)

Status: Terminated

Conditions: Infertility; Preimplantation Genetic Screening

Treatments: Diagnostic Test: Preimplantation Genetic Screening

Study type: Interventional

Funder types: Other

Identifiers

NCT03173885

2016/1235 (Other Identifier)

B670201629937

Details and patient eligibility

About

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).

Enrollment: 56 patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

PGS (genetic screening)

Experimental group

Description:

Intent to transfer single cryopreserved embryo, selection based on euploid status (after preimplantation genetic screening) and standard morphological assessment

Treatment:

Diagnostic Test: Preimplantation Genetic Screening

no PGS (no genetic screening)

No Intervention group

Description:

Intent to transfer single cryopreserved embryo, selection based on standard morphological assessment