Exploring and Validating Biomarkers in Menstrual Blood (MB1)

The main aim of this study is to find out whether menstrual blood collected using a menstrual cup can provide similar useful biological information to a standard blood sample taken from a vein in the arm as well as self-administered vaginal swabs and uterine biopsies.The secondary aims of the study are to assess how practical and acceptable it is to collect menstrual blood in a clinic setting, whether these samples can be processed reliably in the laboratory, and whether menstrual blood contains similar useful biological information to a standard blood sample.Menstrual blood is an under-studied biological sample that may contain useful information about reproductive health and general biological processes. At present, standard blood samples are commonly used in research, additionally vaginal swabs and uterine biopsies are invasive techniques but menstrual blood may provide similar or additional information in a less invasive and more relevant way for some aspects of women's health.

There is currently limited evidence on whether menstrual blood can be collected, processed and analysed reliably for this purpose. This study is therefore needed to assess whether menstrual blood could be used alongside or in some cases instead of standard blood sampling in future women's health research.This is a multi-centre observational research study involving women aged 18 years and over who are currently menstruating. Participants will be recruited through participating fertility clinics.

Potential participants will be provided with a Participant Information Sheet and given time to consider participation.

Those who agree to take part will provide written informed consent before any study procedures are carried out.

Participants will attend a study visit during menstruation. At this visit, a trained member of staff will collect a small blood sample from a vein in the arm, this is part of a standard routine care blood draw. Participants will also provide a menstrual blood sample collected using a menstrual cup and a self administered vaginal swab All samples will be labelled with a unique study code and transferred to the research laboratory for processing and analysis. The study will compare information obtained from menstrual blood and standard blood samples to assess whether menstrual blood can be used as a useful biological sample for research. Some samples may be analysed immediately, while others may be stored temporarily as part of this ethically approved study. Samples will also undergo DNA extraction and cell isolation for research purposes.

There are no follow-up visits planned as part of this study, and participants will not receive individual test results.

Participation ends once the study samples have been collected. However some follow up appointments may be required for example if insufficient sample is obtained first time.