Condition category
Pregnancy and Childbirth
Date applied
08/01/2015
Date assigned
12/01/2015
Last edited
26/01/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The EmbryoScope™ is an IVF incubator with built in camera that monitors the development of embryos around the clock. It provides a safe incubator environment from conception thogh to time of transfer.
This trial examines whether an Embryoscope provides a better environment to culture embryos in when compared to a traditional MINC benchtop incubator. The Embryoscope allows the developing embryo to be imaged at regular intervals without removing them from the incubator thus providing them with a constant environment.

Who can participate?
Couples who have more than 6 healthy embryos.

What does the study involve?
The embryos are randomly allocated into one of two groups. Thise in group 1 are placed in the EmbryoScope™. Those in group 2 are placed in the MINC incubator. The embryos are assessed by examining their structure and form (morphology) and how this changes over time (morphokinetics). In addition to this, the metabolism of the embryos are examined by measuring the concentrations of essential nutrients in the culture medium. This is because it is thought that "quiet" embryos i.e. those who use less nutrients, are in fact more viable.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University of Southampton (UK)

When is the study starting and how long is it expected to run for?
January 2015 to December 2015

Who is funding the study?
1. Unisense FertiliTech A/S (Denmark)
2. National Institute for Health Research (UK)

Who is the main contact?
Dr Alexandra Kermack

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alexandra Kermack

ORCID ID

Contact details

University of Southampton
Academic Unit of Genetic Medicine
Coxford Road
Southampton
SO16 5YA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17907

Study information

Scientific title

PROMOTE: A Prospective Randomised trial cOmparing embryo Metabolism and develOpmenT in the standard versus the Embryoscope incubator

Acronym

PROMOTE

Study hypothesis

Are embryos cultures in an Embryoscope more likely to reach blastocyst stage when compared with those cultured in a MINC benchtop incubator? The research question is being posed because the Embryoscope is an incubator which allows embryos to be observed without removing them from the culture chamber, and there is some evidence to suggest that these embryos benefit from more stable conditions.

Ethics approval

NRES Committee South Central – Berkshire, 03/11/2014, ref: 14/SC/1260

Study design

Randomised; Interventional

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Reproductive health and childbirth; Subtopic: Reproductive Health and Childb (all Subtopics); Disease: Reproductive Health & Childbirth

Intervention

1. Embryoscope: Half of the female participant's embryos will be cultured in the Embryoscope
2. MINC benchtop incubator: Half of the female participant's embryos will be cultured in the MINC benchtop incubator

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Proportion of embryos reaching blastocyst stage in Embryoscope versus MINC benchtop incubator on day 5 after culture in the Embryoscope

Secondary outcome measures

1) A comparison of the mean morphology score of embryos from each cohort on day 5 after culture in the Embryoscope versus the MINC incubator.
2) Number of embryos suitable for cryopreservation from Embryoscope versus MINC
3) Number of “usable” embryos from Embryoscope versus MINC
4) Implantation rate in relation to metabolic activity of embryo(s) transferred
5) A comparison of the amino acid profile in the conditioned media obtained from blastocysts after culture in the Embryoscope versus the MINC Incubator
6) Correlation between metabolic activity and embryo viability as assessed by morphological and morphokinetic assessment

Overall trial start date

05/01/2015

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Standard indication for IVF/ICSI treatment
2. Good understanding of written and spoken English
3. Female age under 42
4. Antral Follicle Count (AFC) of more than 15 or Anti Mullerian Hormone (AMH) of more than 10pmol/l

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 120; UK Sample Size: 120; Description: 60 couples but consented individually

Participant exclusion criteria

1. Any medical contraindication to IVF/ICSI
2. Previous diagnosis of HIV, Hep B or Hep C
3. High risk of Ovarian Hyperstimulation Syndrome (OHSS) as assessed prior to triggering of final oocyte maturation
4. Less than 6 2PN zygotes or more than 14 2PN zygotes available for culture

Recruitment start date

15/01/2015

Recruitment end date

30/10/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Southampton
Academic Unit of Genetic Medicine Coxford Road
Southampton
SO16 5YA
United Kingdom

Sponsor information

Organisation

Southampton University Hospitals NHS Trust

Sponsor details

Cancer Care Directorate
B Level
Mailpoint WRE
Royal South Hants Hospital
Graham Road
Southampton
SO14 0YG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Unisense FertiliTech A/S (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes