Investigating the Cryopreserved Blastocyst's ImplantatiOn Potential After Genetic Screening

Not Applicable

Terminated

• Conditions: Infertility; Preimplantation Genetic Screening
• Interventions: Diagnostic Test: Preimplantation Genetic Screening

• Registration Number: NCT03173885
• Lead Sponsor: University Hospital, Ghent

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-18
• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-05-31
• Study First Posted: 2017-06-02
• Status Verified: 2019-10
• Primary Completion: 2020-02-05
• Study Completion: 2020-02-05
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PGS (genetic screening)	Preimplantation Genetic Screening	Intent to transfer single cryopreserved embryo, selection based on euploid status (after preimplantation genetic screening) and standard morphological assessment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
Aneuploidy	At delivery	Rate of aneuploid versus rate of euploid embryos in PGS arm.

Trial Locations

Locations (1)

Ghent University Hospital - Department of Reproductive Medicine; 🇧🇪 Ghent, Belgium