Preimplantation Genetic Screening in IVF Treatment

Infertility Clinical Trial

— PGSINIVF  

Official title:

Preimplantation Genetic Testing for Aneuploidy (PGT-A) in in Vitro Fertilisation (IVF) Treatment: Pilot Phase of a Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05009745
• Other study ID #: 236067
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: February 2023

Study information

• Verified date: August 2021
• Source: King's College London
• Contact: Sponsor Representative
• Phone: +44 2071889811
• Email: R&D[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is the pilot phase of a randomised controlled trial.

The purpose of the pilot study is to assess the ability to recruit, randomise, adherence to the study protocol and plan for a full study.

The purpose of the full study will be to determine if a policy of embryo selection and transfer based on morphological evaluation and preimplantation genetic testing for aneuploidy (PGT-A) is a more clinically effective, safer, cost-effective and acceptable way to provide in vitro fertilisation (IVF) treatment in women of advanced reproductive age compared to the routine practice of embryo selection and transfer based on morphological evaluation alone.

Description:

The target population for the trial are women aged 35 - 42 years undergoing IVF±ICSI treatment.

Intervention The experimental strategy will be to perform PGT-A (also referred as preimplantation genetic screening - PGS) involving trophectoderm biopsy on embryos reaching the blastocyst stage on day 5/6/7 following egg collection. All embryos will be frozen after the biopsy procedure.

Comprehensive chromosome screening (CCS) of all chromosomes will be performed using next generation sequencing (NGS). Embryos will be categorised as euploid, mosaic euploid and aneuploid embryos and embryos will be ranked based on the degree of euploidy.

Only euploid embryos or mosaic euploid embryos deemed suitable to be replaced will be transferred in subsequent frozen-thawed embryo transfer cycles.

Comparison Women in the control arm will have the fresh embryo transfer procedure on day 5 following egg collection or a frozen-thawed embryo transfer as first line if clinically indicated in keeping with current routine practice. Embryo selection for transfer will be based on morphological criteria alone.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 42 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria for the study would be women aged 35 - 42 years undergoing IVF ± ICSI for treatment of infertility

• Patients with 3 or more good quality embryos (assessed according to the embryo scoring system of the Association of Clinical Embryologists, UK) on day 3 following egg collection

• Ability to provide informed written consent

Exclusion Criteria:

• Women undergoing preimplantation genetic testing for inherited genetic disorders

• Gamete donation cycles

• Untreated hydrosalpinges

• Untreated uterine pathology (eg: endometrial polyps, submucous fibroids, intramural fibroids > 5 centimetres in maximum diameter, intrauterine adhesions, uterine septa)

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• PGT-A Strategy
PGT-A strategy involves trophectoderm biopsy, comprehensive chromosome screening (CCS) using Next Generation Screening (NGS), freezing of embryos and replacement in a frozen-thawed embryo transfer cycle.

Locations

Country	Name	City	State
United Kingdom	King's Fertility	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Pilot phase RCT with an aim to progress to a multi-centre RCT	18 months
Secondary	Clinical pregnancy rate	Clinical pregnancy is defined as presence of an intrauterine gestational sac with a foetal pole and heart beat identified by ultrasound scan.	21 months