PROMOTE: A prospective randomised trial comparing embryo development

Not Applicable

Completed

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

• Registration Number: ISRCTN73037149
• Lead Sponsor: Southampton University Hospitals NHS Trust

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36287638/ (added 27/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-12
• Study Completion: 2015-12-31
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 2. Number of embryos suitable for cryopreservation from Embryoscope versus MINC<br> 3. Number of usable” embryos from Embryoscope versus MINC<br> 4. Implantation rate in relation to metabolic activity of embryo(s) transferred<br> 5. A comparison of the amino acid profile in the conditioned media obtained from blastocysts after culture in the Embryoscope versus the MINC Incubator<br> 6. Correlation between metabolic activity and embryo viability as assessed by morphological and morphokinetic assessment<br>