PROMOTE: A prospective randomised trial comparing embryo development

ISRCTN	ISRCTN73037149
DOI	https://doi.org/10.1186/ISRCTN73037149
Protocol serial number	17907
Sponsor	Southampton University Hospitals NHS Trust
Funders	Unisense FertiliTech A/S (Denmark), National Institute for Health Research

Submission date: 08/01/2015
Registration date: 12/01/2015
Last edited: 27/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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. Those 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

Contact information

Dr Alexandra Kermack
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised; Interventional
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	PROMOTE: A Prospective Randomised trial cOmparing embryo Metabolism and develOpmenT in the standard versus the Embryoscope incubator
Study acronym	PROMOTE
Study objectives	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(s)	NRES Committee South Central – Berkshire, 03/11/2014, ref: 14/SC/1260
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Proportion of embryos reaching blastocyst stage in Embryoscope versus MINC benchtop incubator on day 5 after culture in the Embryoscope
Key secondary outcome measure(s)	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
Completion date	31/12/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	120
Key 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
Key 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
Date of first enrolment	15/01/2015
Date of final enrolment	30/10/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Southampton

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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		26/10/2022	27/10/2022	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

27/10/2022: Publication reference added.
19/01/2018: No publications found, verifying study status with principal investigator.