Exploring and Validating Biomarkers in Menstrual Blood

NCT07638085 | Not Yet Recruiting

• 1 other identifier: 1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fertility

Keywords

non invasive; menstrual blood; infertility

Outcome Measures

Primary Outcomes (1)

• Pregnancy percentage

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

  2 months

Secondary Outcomes (1)

• Live birth

  10 months

Study Arms (2)

People with no fertility isssues

People such as egg donors, frozen egg patients who are doing IVF without having had any fertility issues

People with fertility issues

People with infertility

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who have been through menarche and are considering fertility treatment, and menstruate without debilitating gynecological conditions

You may not qualify if:

• 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

Sponsors & Collaborators

• Genie Fertility Ltd: lead
• CRGH Fertility Clinic London: collaborator

Study Sites (1)

Genie Fertility

London, ENG, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum, and microbial DNA will be retained

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Andreas Hadjimitsis, Phd

CONTACT

+447780440936; andreas@geniefertility.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)