MONITOR US WP3
Research type
Research Study
Full title
Feasibility cohort study: Serum mid-luteal progesterone versus ultrasound for monitoring first-cycle clomifene citrate.
IRAS ID
247059
Contact name
Heather Garthwaite
Contact email
Sponsor organisation
University of Sunderland
Duration of Study in the UK
1 years, 8 months, 31 days
Research summary
Research question: When clomifene is used for fertility problems, does ultrasound monitoring reduce the risk of multiple pregnancy?
Clomifene is a medication used to trigger the ovary to release an egg (ovulate). Guidelines state that ultrasound should be used after clomifene is first given, to assess how many eggs have developed. Where there are multiple eggs, there may be an increased likelihood of multiple pregnancy (twins, triplets etc.), and the couple would be advised to avoid unprotected intercourse that month. This is because multiple pregnancies carry extra risks to mother and baby.
The guidance to use ultrasound for this purpose is not based on any research evidence because there is currently none available.
Progesterone is a hormone produced in the ovary following ovulation. Using a blood test for progesterone can indicate if clomifene has successfully triggered ovulation, but gives no information about multiple pregnancy risk.
The aim of this study is to explore the feasibility of conducting a full retrospective cohort study to compare multiple pregnancy rates between those patients whose first cycle of treatment is monitored with ultrasound, and those who are not monitored with ultrasound. The secondary aim is to assess the clinical and financial implications of using a blood test (progesterone level) as an alternative monitoring method.This study will comprise various strategies of data collection from the medical records of patients who have completed treatment with clomifene. They will be split into two arms (monitored with ultrasound and not monitored with ultrasound), then the pregnancy outcomes will be compared based on the data gathered. This will be followed by an initial cost effectiveness analysis for each study arm.
The study will last for 22 months and will take place in HFEA-licensed fertility departments, in the NHS and the private sector. It is funded by Health Education England (North East).
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
19/SW/0059
Date of REC Opinion
30 May 2019
REC opinion
Favourable Opinion