Reframing Endometrial Physiology by Advanced Integrated Research

NCT07557992 | Recruiting

• 2 other identifiers: O&G0334362221
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Heavy menstrual bleeding (HMB) affects 1 in 3 women and can significantly impact quality of life. Despite its prevalence, there is no accessible and accurate diagnostic test. This research will use wearable sensors, magnetic resonance imaging (MRI) scans, and biological sample collection to identify changes in the uterus linked with HMB. The investigators aim to recruit approximately 130 participants across two study sites over three years, including people with and without HMB.

Conditions

Menorrhagia Due to Benign Causes

Keywords

menorrrhagia; heavy menstrual bleeding; electrophysiology; uterine contractility

Outcome Measures

Primary Outcomes (1)

• Frequency of uterine contractions (contractions per minute) measured using cine MRI (HASTE vs TRUFI sequences)

  Frequency of uterine contractions quantified from cine MRI sequences and compared between participants with heavy menstrual bleeding and controls.

  Cycle 1, Days 18-21 (luteal phase; each cycle is 28 days)

Secondary Outcomes (6)

• Dominant frequency of uterine bioelectrical activity measured by wearable pelvic electrodes

  Cycle 1, Days 18-21 (luteal phase) and Cycle 2 Days 1-5 (menstruation) (each cycle is 28 days)

• Acceptability of wearing device (usability score)

  Cycle 2, Days 1-5 (menstruation; each cycle is 28 days)

• Molecular markers in endometrial biopsy sample

  Cycle 1 (each cycle is 28 days), assessed at Days 1-5 (menstruation) and Days 18-21 (luteal phase)

• Molecular markers in vaginal swab samples

  Cycle 1, Days 1-5 (menstruation); Days 6-10 (post-menstruation); and Days 18-21 (luteal phase) (each cycle is 28 days)

• Molecular markers in menstrual effluent

  Cycle 1 (each cycle is 28 days), assessed at Days 1-3 (menstruation)

Study Arms (2)

Menorrhagia

diagnosed heavy periods with haematin test (\>/80ml)

Normal periods

not diagnosed as heavy with haematin test (\<80ml)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Must have cervix, uterus and have periods to participate
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from in and around Hampshire with the ability to attend Southampton General Hospital for appointments. They will be recruited from both within hospital settings but also the community as many women suffer with HMB without seeking support.

You may qualify if:

• Having Periods

You may not qualify if:

• Currently pregnant or breastfeeding.
• Known uterine malignancy, severe anaemia requiring urgent treatment, or other acute gynaecological emergencies.
• Inability to undergo MRI (e.g., pacemaker, severe claustrophobia).
• Inability to provide informed consent.
• Current use of hormonal treatment, or use in the last 2 months

Sponsors & Collaborators

• University of Auckland, New Zealand: collaborator
• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

University Hospital Southampton

Southampton, so16 6yd, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Endometrial tissue samples

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• Ying Cheong

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Cheong

CONTACT

+44 7977011443; y.cheong@soton.ac.uk

Study Design

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

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: April 30, 2026
• Study Start: February 6, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: April 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)