Investigating the Cryopreserved Blastocyst's ImplantatiOn Potential After Genetic Screening

NCT ID: NCT03173885

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-18
• Study Completion Date: 2020-02-05

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).

Conditions

Infertility; Preimplantation Genetic Screening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PGS (genetic screening)

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

Group Type: EXPERIMENTAL

Preimplantation Genetic Screening

Intervention Type: DIAGNOSTIC_TEST

• laser assisted hatching
• trophectoderm biopsy
• next generation sequencing

no PGS (no genetic screening)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Preimplantation Genetic Screening

• laser assisted hatching
• trophectoderm biopsy
• next generation sequencing

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Petra De Sutter, M.D; PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Ghent University Hospital - Department of Reproductive Medicine

Ghent, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 32898291 (View on PubMed)

Other Identifiers

2016/1235

Identifier Type: OTHER

Identifier Source: secondary_id

B670201629937

Identifier Type: -

Identifier Source: org_study_id