Exploring and Validating Biomarkers in Menstrual Blood

NCT07638085 · tracked via the Priya Life Science UK tracker

Sponsor

Genie Fertility Ltd

Phase

Observational

Started

2026-07-01

Last updated

2026-06-10

Condition(s) studied

Fertility

Study summary

This study aims to find out whether menstrual blood can provide similar useful biological information to a standard blood sample taken from a vein in the arm as well as uterine biopsies and vaginal swabs.

Menstrual and reproductive health have historically been under-represented in research, and menstrual blood remains an under-studied biological sample despite its potential value for understanding women's health.

Women aged 18 years and over who are currently menstruating may be invited to take part. Participants will attend a study visit during their menstrual period, where they will provide a menstrual blood sample collected using a menstrual cup and a small blood sample from a vein in the arm.The samples will be sent to a research laboratory and analysed to compare the biological information they contain.

Some samples may also be processed to extract DNA and isolate cells for research purposes.

The study is low risk and is not expected to provide a direct medical benefit to participants. However, it may help improve understanding of whether menstrual blood could be used more widely in future women's health and fertility research. Participants will not receive individual results, as the tests are for research purposes only and are not designed to provide clinical information about their health.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria:Are female and aged 18 years or over Experienced menarche but not menopause Are willing and able to provide a menstrual blood sample collected using a menstrual cup Are willing to provide a self-administered vaginal swab Are willing and able to undergo collection of a peripheral venous blood sample Are able to understand the study procedures and requirements Are able and willing to provide written informed consent Are willing for their samples and associated study data to be used for the research purposes described in the study documentation Participants may be recruited from participating fertility clinics. \- Exclusion Criteria: * Are male or 17 years or younger Not experienced menarche or experienced menopause Currently pregnant Have an active vaginal, pelvic or systemic infection that may affect safe participation or sample integrity Have a known allergy, sensitivity or intolerance to the menstrual cup material Have any medical, anatomical or physical condition that would make use of a menstrual cup unsafe or impractical Have any condition which, in the opinion of the investigator or delegated clinician, would make participation unsafe, inappropriate or unsuitable Are unable or unwilling to provide written informed consent

Primary outcome measure(s)

Pregnancy percentage — 2 months
The pregnancy result of a patient after IVF treatment, and percentage of patients who become pregnant

Trial sites (1)

Facility	City	Region	Status
Genie Fertility	London	ENG

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07638085 on ClinicalTrials.gov ↗ ← All trials in the UK