Preimplantation Genetic Screening in IVF Treatment (PGSINIVF)

August 12, 2021 updated by: King's College London

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sponsor Representative
  • Phone Number: +44 2071889811
  • Email: R&D@gstt.nhs.uk

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 42 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention

The intervention will be PGT-A strategy involving trophectoderm biopsy and comprehensive chromosome screening (CCS) using Next Generation Sequencing (NGS). All embryos will be frozen after the biopsy procedure and transferred in a subsequent frozen-thawed embryo transfer. Embryo selection for transfer will be based on morphological criteria and the genetic screening result.

Only euploid embryos or mosaic euploid embryos deemed suitable to be transferred will be replaced into the uterus in a subsequent frozen-thawed embryo transfer cycles.
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.
Other Names:
  • PGS Strategy
NO_INTERVENTION: Control arm
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 over a fresh embryo transfer, if clinically indicated. Embryo selection for transfer will be based on morphological criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 18 months
Pilot phase RCT with an aim to progress to a multi-centre RCT
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 21 months
Clinical pregnancy is defined as presence of an intrauterine gestational sac with a foetal pole and heart beat identified by ultrasound scan.
21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

Guy's and St Thomas' NHS Foundation Trust

Investigators

  • Principal Investigator: Sesh K Sunkara, MD, FRCOG, King's College London
  • Principal Investigator: Ippokratis Sarris, MD, MRCOG, King's Fertility, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 10, 2021

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

February 1, 2023

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

August 12, 2021

First Posted (ACTUAL)

August 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 236067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

If there was to be an individual participant data (IPD) meta-analysis on this topic or similar collaboration with other researchers in future, we will share IPD with other researchers.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Clinical Trials on PGT-A Strategy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe