Clinical Symptom and Biomarker Prediction Model in Reproductive Health
Research type
Research Study
Full title
The use of a combined clinical symptom and biomarker-based model to predict risk of developing reproductive conditions and fertility potential.
IRAS ID
270704
Contact name
Paul Hardiman
Contact email
Sponsor organisation
Royal Free London
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This project seeks to gather information from finger prick blood tests to create a computational algorithm for predicting future female fertility.
Maintaining reproductive health, such as successful pregnancy, requires a complex calculus of ovulation and menstrual cycles, lifestyle factors and stable hormone levels. Reproductive health relies on precise synchronisation of all these variables. However, almost 30% of women have some varying degree of malfunction in one or more of these factors that can disrupt their reproductive cycle and lead to infertility.
Much of the data concerning the multi-factorial variables involved in pregnancy, has been generated from small scale studies on a clinically diagnosed sub-fertile (delay in conceiving) population. Consequently, there is a lack of data available from females who are yet to attempt conception or who present with atypical symptoms.
These symptoms often overlap with other common conditions (e.g., heavy periods, irritable bowel syndrome or interstitial cystitis), making diagnosis challenging in primary care. Moreover, current NICE guidelines for routine gynaecological evaluation in primary care, limits laboratory tests and female hormone testing (biomarkers). As a consequence of this diagnostic framework, diagnosis is often delayed, on average 6–12 years after initially presenting with symptoms.
We will use a patient symptom-based care questionnaire designed to allow women to self-identify symptoms. We will then combine comprehensive biomarker tests from the blood to create a computational algorithm, with the view to facilitate clinician and patient discussions, with the potential to reduce diagnostic delay and encourage earlier treatment. By applying this model to the wider population, we hope that each woman’s own symptoms and biology can be used to indicate the potential risk to her fertility and reproductive health.REC name
London - Surrey Research Ethics Committee
REC reference
20/LO/0265
Date of REC Opinion
29 Apr 2020
REC opinion
Further Information Favourable Opinion