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Register:	ISRCTN
Last refreshed on:	7 November 2022
Main ID:	ISRCTN73037149
Date of registration:	12/01/2015
Prospective Registration:	Yes
Primary sponsor:	Southampton University Hospitals NHS Trust
Public title:	PROMOTE: A prospective randomised trial comparing embryo development
Scientific title:	PROMOTE: A Prospective Randomised trial cOmparing embryo Metabolism and develOpmenT in the standard versus the Embryoscope incubator
Date of first enrolment:	15/01/2015
Target sample size:	120
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN73037149
Study type:	Interventional
Study design:	Randomised; Interventional (Treatment)
Phase:	Not Applicable

Countries of recruitment
England	United Kingdom

Contacts

Name:	Alexandra Kermack
Address:	University of Southampton Academic Unit of Genetic Medicine Coxford Road SO16 5YA Southampton United Kingdom
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
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Affiliation:

Key inclusion & exclusion criteria

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

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

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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

Primary Outcome(s)

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

Secondary Outcome(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

Secondary ID(s)

17907

Source(s) of Monetary Support

Unisense FertiliTech A/S (Denmark), National Institute for Health Research

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

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

Results

Results available:	Yes
Date Posted:
Date Completed:	31/12/2015
URL:

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