Biomarkers of ovarian ageing in post-menopausal women living with HIV
Research type
Research Study
Full title
Biomarkers of ovarian ageing in post-menopausal women living with HIV: a prevalence study
IRAS ID
251390
Contact name
Robert Miller
Contact email
Clinicaltrials.gov Identifier
Z6364106/2018/08/103, UCL Data Protection Registration
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Over 10,000 women aged 45-60 accessed HIV care in 2016; a five-fold increase over ten years. This means that menopause (the point at which women's periods stop due to their ovaries stopping working) is becoming more important in this patient group. National guidelines advise that menopause should be diagnosed based on period pattern in women aged >45. However, we don't know if this approach is valid in women living with HIV (WLHIV), who may be more likely to have other reasons for their periods stopping apart from menopause. Accurate diagnosis of menopause in women living with HIV is important in ensuring that they receive the right support and treatment.
This study will examine follicle-stimulating hormone (FSH) in WLHIV aged 45-60 at entry into the PRIME study (Positive tRansItions through the MEnopause, www.ucl.ac.uk/prime-study). PRIME is a study of HIV and menopause that recruited 879 WLHIV aged 45-60 across 21 HIV clinics in England in 2016-2017. FSH is a hormone that goes up when a woman reaches menopause. We will recruit 100 women from PRIME who were assessed as being perimenopausal (around the time of menopause, based on having irregular periods) when they first entered the study, and who now report ≥12 months without a period (therefore potentially having reached menopause). We will ask women to complete a short paper questionnaires, collect data from clinical databases, and take a blood test to measure FSH in order to find out menopausal status.We expect that WLHIV who are postmenopausal (not having had a period for ≥12 months) will have elevated FSH levels. This will help us find out if we can diagnose menopause by period pattern alone in WLHIV, which could save unnecessary blood tests.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
18/SC/0570
Date of REC Opinion
9 Oct 2018
REC opinion
Favourable Opinion