Preimplantation Genetic Testing for Aneuploidies in Patients With Recurrent Implantation Failure

Recurrent Implantation Failure Clinical Trial

Official title:

Preimplantion Genetic Testing for Aneuploidies (PGT-A) in Patients With Recurrent Implantation Failure: a Pilot RCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03900780
• Other study ID #: S62302
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: December 1, 2023

Study information

• Verified date: September 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Myriam Welkenhuysen
• Phone: +3216343544
• Email: myriam.welkenhuysen[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assessing whether Preimplantation Genetic Testing for Aneuploidy (PGT-A) can increase the ongoing pregnancy rate per transferred embryo and can decrease the time to pregnancy and miscarriage rate in patients with Recurrent Implantation Failure (RIF)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women with recurrent implantation failure (previous transfer of least 4 good quality embryos in at least 3 fresh or frozen cycles)
• BMI < 35
• Normal hysteroscopy

Exclusion Criteria:

• thin endometrium in previous cycles (<6mm), endometriosis ASRM score III-IV, premature ovarian failure (POF, Bologna criteria), abnormal karyotype, donor oocytes or embryos, PGT-M

Related Conditions & MeSH terms

• Aneuploidy
• Recurrent Implantation Failure

Intervention

Procedure:
• PGT-A
ovarian stimulation, oocyte aspiration, embryo culture until the blastocyst stage (day 5/6), TE biopsy, vitrification of all embryos in the blastocyst stage, PGT-A by NGS and finally embryo transfer of genetically normal embryos in cumulative frozen-thawed embryo transfer cycles
• Control
ovarian stimulation, oocyte aspiration, embryo culture until the blastocyst stage, fresh embryo transfer of the morphologically best embryo on day 5/6, vitrification of supernumerary embryos and embryo transfer in cumulative frozen-thawed embryo transfer cycles if not pregnant from the fresh cycle.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OPR	Ongoing pregnancy rate per embryo transfer	at 20 weeks gestational age
Secondary	IR	Implantation rate per transferred embryo	2 weeks