PROMOTE: A prospective randomised trial comparing embryo development
| ISRCTN | ISRCTN73037149 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73037149 |
| Secondary identifying numbers | 17907 |
- 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
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. 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
Scientific
University of Southampton
Academic Unit of Genetic Medicine
Coxford Road
Southampton
SO16 5YA
United Kingdom
Study information
| Study design | Randomised; Interventional |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 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(s) | NRES Committee South Central – Berkshire, 03/11/2014, ref: 14/SC/1260 |
| 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 |
| Primary outcome measure | 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 study start date | 05/01/2015 |
| Overall study end date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Planned Sample Size: 120; UK Sample Size: 120; Description: 60 couples but consented individually |
| 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 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
- England
- United Kingdom
Study participating centre
Coxford Road
Southampton
SO16 5YA
United Kingdom
Sponsor information
Hospital/treatment centre
Cancer Care Directorate
B Level, Mailpoint WRE
Royal South Hants Hospital
Graham Road
Southampton
SO14 0YG
England
United Kingdom
"ROR" |
https://ror.org/0485axj58 |
|---|
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
27/10/2022: Publication reference added.
19/01/2018: No publications found, verifying study status with principal investigator.
