Reproduction-related tissues on a cellular level (BLEEDS) (IRAS 356429)

Millions of people live with gynaecological conditions like endometriosis and adenomyosis, yet these disorders remain difficult to diagnose without invasive procedures. We think menstrual fluid, a sample that's usually overlooked, could hold the answers. It naturally reflects what's happening inside the uterus, so by studying it closely, we may be able to spot signs of disease without surgery. We'll collect samples from healthy volunteers and people with gynaecological conditions, then use advanced technology to examine the individual cells within the fluid and compare them across groups. We'll even grow some of these cells in the lab to create tools for future research. Our hope is to transform how these conditions are diagnosed and treated, improving women's health worldwide.

Menstrual fluid (MF) is a biological sample comprising blood, uterine lining cells, immune cells, and other components shed during menstruation, and offers a largely untapped resource for understanding reproductive health. Using single-cell transcriptomics, we can now identify the cell types present in MF and examine their gene expression, providing insight into their roles in health and disease. As MF reflects physiological changes within the uterus, its analysis may offer a non-invasive approach to detecting gynaecological disorders such as endometriosis and adenomyosis.

This study will collect MF samples from healthy participants and individuals with gynaecological conditions, alongside surgical tissue samples, to determine the cellular composition of MF and how it differs between health and disease. Selected cells will also be cultured to establish models for future research and drug testing. Eligible participants are individuals who menstruate regularly, including those with diagnosed gynaecological conditions. Samples will be collected over five years at the Wellcome Sanger Institute and partner clinical sites. This work has the potential to improve diagnosis and treatment of gynaecological disorders, with significant benefits for women’s health.

Rationale

Menstrual Fluid has emerged as a very promising diagnostic tool for several disorders, but also as a non-invasive source of cells for  in vitro work. Given the historical understudy of women’s health and the additional obstacle of collecting invasive samples from the clinic, Menstrual Fluid presents itself as a readily available resource, which can contribute to projects of very different nature – from descriptive to pre-clinical. We want to use this rich, understudied source of cells to answer basic questions about the physiological state of the reproductive system. We also want to put our findings about the Menstrual Fluid in a more systemic context by also building on our knowledge of the other
reproduction-related tissues through collections and profiling of different types of samples.

Aims

The study aims to utilise reproduction-related tissues in particular menstrual fluid to investigate generate an atlas of the human tissue and the associated microbiota present in the collected tissues and to develop an in vitro platform for mechanistic validation.

Primary Outcome

Single-cell and spatial transcriptomic analysis from at least one hundred individuals

Key Secondary outcome(s)

None

Study Type

Observational

Participant and Sample Information

Populations involved:

Healthy individuals and those with gynaecological conditions.

Countries of recruitment:

UK

Approximate participant or sample numbers (if applicable):

100

Key inclusion criteria:

• Participants must be menstruating individuals.
• Healthy participants must be willing and able to collect and donate menstrual fluid for use in this study.
• Participants with underlying gynaecological disorders (e.g. endometriosis, heavy menstrual bleeding, uterine fibroids) must be willing and able to have additional biopsies collected at the time of routine surgery for use in this study.
• Alternatively, participants with underlying gynaecological disorders must be willing and able to collect and donate menstrual fluid for use in this study.
• Participants must have a good command of the English language.

Key exclusion criteria:

• Individuals with a previous diagnosis of cancer of the reproductive tract (e.g. ovarian cancer, uterine cancer).
• Individuals who meet the inclusion criteria but are unwilling or unable to donate samples for use in the study.
• Individuals unable to speak English, and therefore unable to give informed consent without translated documentation.

Recruitment status:

Recruiting by invitation only.

Governance and Ethical Approval

Governance and oversight:

Study Sponsor: Wellcome Sanger Institute

All work conducted at the Wellcome Sanger Institute is reviewed and overseen by institutional Research Governance processes, ensuring compliance with ethical, legal, and regulatory requirements.

Ethical approval:

This study has been reviewed by the London – Stanmore NHS Research Ethics Committee. The study received REC approval on 10 June 2025.

IRAS 356429

REC reference: 25/LO/0357

Data and Sample Use

Data sharing:

Anonymised DNA sequence data are stored in the European Genome-Phenome Archive (EGA) and made available to bonafide researchers via managed access, subject to data access agreements. Anonymised samples and cultured cells may also be shared with other legitimate research organisations under appropriate legal agreements.

IPD sharing statement

Deidentified individual participant-level data (IPD) will not be shared as part of this study.

Completion date

Ongoing

Further Information

For enquiries about the scientific aims of this study or potential collaboration, please contact the relevant scientific programme at https://www.sanger.ac.uk/group/vento-tormo-group/.

For enquiries relating to research governance, ethics, or regulatory oversight, please contact the Research Governance team at researchgovernance@sanger.ac.uk.