Investigating the Cryopreserved Blastocyst's ImplantatiOn Potential After Genetic Screening

Infertility Clinical Trial

— BIOPS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03173885
• Other study ID #: B670201629937
• Secondary ID: 2016/1235
• Status: Terminated
• Phase: N/A
• Start date: May 18, 2017
• Est. completion date: February 5, 2020

Study information

• Verified date: October 2019
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: February 5, 2020
• Est. primary completion date: February 5, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Infertility
• Preimplantation Genetic Screening

Intervention

Diagnostic Test:
• Preimplantation Genetic Screening
laser assisted hatching trophectoderm biopsy next generation sequencing

Locations

Country	Name	City	State
Belgium	Ghent University Hospital - Department of Reproductive Medicine	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy	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.	At 7 - 8 gestational weeks
Secondary	Biochemical pregnancy	Rate of biochemical pregnancy (a pregnancy diagnosed only by either serum or urine ß-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.	At 7 -8 gestational weeks
Secondary	Clinical miscarriage	Rate of clinical miscarriage (intrauterine pregnancy demise confirmed by ultrasound or histology) after transfer of embryo in PGS arm versus in no PGS arm.	At 7 - 16 gestational weeks
Secondary	Live birth	Rate of live birth (> 24 weeks gestation) after transfer of embryo in PGS arm versus in no PGS arm.	At delivery
Secondary	Aneuploidy	Rate of aneuploid versus rate of euploid embryos in PGS arm.	At delivery