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PROMOTE: A prospective randomised trial comparing embryo development

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN73037149
Enrollment
120
Registered
2015-01-12
Start date
2015-01-15
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Reproductive health and childbirth

Interventions

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 th

Sponsors

Southampton University Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion 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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026