InfertilityPGSINIVFNCT05009745
Preimplantation Genetic Screening in IVF Treatment
A study testing PGT-A Strategy in people with Infertility, run by King's College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 35 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- PGT-A Strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jun 2021to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's Fertility
London
Sesh K Sunkara, sesh.sunkara@kcl.ac.uk
Ippokratis Sarris, ippokratis.sarris@kingsfertility.co.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Infertility
- Being tested
- PGT-A Strategy
- Keywords
- Preimplantation Genetic Testing, IVF, RCT, Pilot Study
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PGT-A StrategyProcedure or surgery
Also called PGS 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Pilot phase RCT with an aim to progress to a multi-centre RCT
Measured: 18 months
Secondary outcomes (1)
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.
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start10 Jun 2021
- Primary completionDec 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot phase of a prospective, allocation concealed two arm parallel RCT
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Sesh K Sunkara, MD, FRCOG, Principal investigator, King's College LondonIppokratis Sarris, MD, MRCOG, Principal investigator, King's Fertility, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009745
- Sponsor's protocol ID
- 236067
- Acronym
- PGSINIVF
- Status last verified
- Aug 2021
- First submitted
- 28 Oct 2020
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39458142
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preimplantation Genetic Testing for Aneuploidy (PGT-A) in in Vitro Fertilisation (IVF) Treatment: Pilot Phase of a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05009745
- Acronym / sponsor ID
- PGSINIVF / 236067
- Conditions
- Infertility
- Keywords
- Preimplantation Genetic Testing, IVF, RCT, Pilot Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot phase of a prospective, allocation concealed two arm parallel RCT
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: PGT-A StrategyThe 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. |
| 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. |
Who may qualify
- Ages
- 35 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PGT-A StrategyAlso: PGS StrategyPGT-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. | Procedure or surgery | Intervention |
Primary outcome
Recruitment rate
Time frame: 18 months
Pilot phase RCT with an aim to progress to a multi-centre RCT
1 secondary outcome
Clinical pregnancy rate
Time frame: 21 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Derived from this study: PubMed 39458142Beebeejaun 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sesh K Sunkara, MD, FRCOG principal investigator
King's College London
Ippokratis Sarris, MD, MRCOG principal investigator
King's Fertility, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PGT-A Strategy in people with Infertility, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sponsor Representative (+44 2071889811, R&D@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05009745, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.