DeCiDE

• Research type

  Research Study

• Full title

  Diagnostic Criteria for Early Embryonic Demise in Assisted Conception (DeCiDE)

• IRAS ID

  340003

• Contact name

  Davor Jurkovic

• Contact email

  davor.jurkovic@nhs.net

• Sponsor organisation

  University College London Hospitals

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  Early embryonic demise (EED) is an ultrasound diagnosis which reflects a miscarriage. Strict criteria exist for the diagnosis of EED because a false positive diagnosis cannot be tolerated, and also due to inherent uncertainty around the exact gestation of spontaneously conceived pregnancies. If the diagnostic criteria are not met at the initial visit, the patient must return for a further scan one to two weeks later, before the diagnosis of early embryonic demise can be confirmed and treatment can be offered. The criteria are designed for spontaneously conceived pregnancies and do not take into account pregnancies conceived by in-vitro fertilisation (IVF), where the exact date of conception is known. We hypothesise that in cases of IVF pregnancies, it should be possible to diagnose early embryonic demise with certainty at the initial visit for a greater proportion of patients than is currently achieved under existing guidelines. The aim of this study is to develop diagnostic criteria for miscarriage in IVF pregnancies and to assess the impact that the utilisation of this criteria would have in reducing the need for follow up in early pregnancy units (EPUs), and ensuring better accuracy and safety of diagnosis.
  This will be a multi-centre, data-only observational study assessing ultrasound appearances and subsequent clinical outcomes in patients with IVF pregnancies. We aim to develop novel diagnostic criteria to facilitate the diagnosis of early embryonic demise in IVF pregnancies without unnecessary delay. Subsequent analysis will determine what proportion of such pregnancies would have required a follow up scan to confirm the diagnosis of early embryonic demise based on existing diagnostic criteria, in order to assess the potential impact that the utilisation of our criteria would have in reducing the need for follow up in IVF pregnancies.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  24/SC/0295

• Date of REC Opinion

  30 Aug 2024

• REC opinion

  Favourable Opinion