MONITOR US WP2

• Research type

  Research Study

• Full title

  Feasibility of implementing serum mid-luteal progesterone measurement and/or transvaginal ultrasound for clomifene citrate monitoring in primary care: attitudes and perceptions of patients, GPs and fertility specialists

• IRAS ID

  232665

• Contact name

  Heather Garthwaite

• Contact email

  heather.garthwaite@research.sunderland.ac.uk

• Sponsor organisation

  University of Sunderland

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  Background
  Approximately 25% of fertility problems are due to disorders of ovulation. Such problems can be successfully treated with a medication called clomifene citrate, which stimulates the ovary to release an egg.
  NICE guidance advises ultrasound monitoring after the first-cycle of treatment, to assess for multifollicular development and hence the risk of multiple pregnancy (twins, triplets etc.). This guidance is not evidence-based, and we know from recent research, that doctors will often use a blood test for mid-luteal progesterone level instead; this indicates if ovulation has occurred, but gives no information about multiple pregnancy risk.
  Currently, clomifene is usually prescribed in hospital settings, even though patients have previously expressed a preference to receive this treatment from their GP. One of the reasons for referral to hospital may be the requirement for ultrasound.

  Aim
  The aim of this study is to explore the views of fertility specialists, GPs and patients regarding the potential use of clomifene in primary care settings, without direct access to ultrasound. This will precede further study to investigate the safety of managing clomifene in this way.

  Design
  This study will consist of approximately 30 in-depth interviews with fertility specialists, GPs and patients, to explore views and preferences about management with clomifene in GP and hospital settings.

  Duration and setting
  The study is intended to last for twelve months. It will be conducted in GP surgeries, gynaecology outpatient departments and specialist fertility services in the UK.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  17/NE/0372

• Date of REC Opinion

  7 Dec 2017

• REC opinion

  Favourable Opinion