NCT05009745

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

June 10, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

October 28, 2020

Last Update Submit

August 12, 2021

Conditions

Infertility

Keywords

Preimplantation Genetic TestingIVFRCTPilot Study

Outcome Measures

Primary Outcomes (1)

  • Recruitment rate

    Pilot phase RCT with an aim to progress to a multi-centre RCT

    18 months

Secondary Outcomes (1)

  • Clinical pregnancy rate

    21 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control arm

NO INTERVENTION

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.

Interventions

PGT-A StrategyPROCEDURE

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.

Also known as: PGS Strategy
Intervention

Eligibility Criteria

Age35 Years - 42 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's Fertility

London, United Kingdom

RECRUITING

Related Publications (1)

  • Beebeejaun Y, Nicolaides KH, Mania A, Sarris I, Sunkara SK. Preimplantation Genetic Testing for Aneuploidy (PGT-A) in In-Vitro Fertilisation (IVF) Treatment: Study Protocol for Pilot Phase of a Randomised Controlled Trial. J Clin Med. 2024 Oct 17;13(20):6192. doi: 10.3390/jcm13206192.

    PMID: 39458142DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Sesh K Sunkara, MD, FRCOG

    King's College London

    PRINCIPAL INVESTIGATOR

  • Ippokratis Sarris, MD, MRCOG

    King's Fertility, London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sponsor Representative

CONTACT

+44 2071889811R&D@gstt.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The participants, care providers, investigators and outcome assessors will not be masked.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Pilot phase of a prospective, allocation concealed two arm parallel RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

August 17, 2021

Study Start

June 10, 2021

Primary Completion

December 1, 2022

Study Completion

February 1, 2023

Last Updated

August 17, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

GB(1)