Identification of Biomarkers in Cervical Mucus (IBISCUS)

March 23, 2026 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Identification of Diagnostic, Prognostic and Predictive Biomarkers in Cervical Mucus for Reproductive and Gynecological Disorders

Cervical mucus is a biological fluid secreted by the endocervical glandular epithelium whose quantitative and qualitative characteristics vary in response to the hormonal stimulus produced by the ovary during the woman's menstrual cycle. As a fertility factor, it performs numerous biological functions: transport, nourishment, defense and capacitation of spermatozoa, defense against pathogens of the female genital tract.

The aim of this research will be to deepen the knowledge of the biochemical characteristics of cervical mucus, in particular to perform characterization by infrared spectroscopy, for the identification of diagnostic, prognostic and predictive biomarkers for disorders affecting the female reproductive system.

A healthy control population and a cohort of patients affected by unexplained infertility will be enrolled for the longitudinal study of the menstrual cycle with ultrasound and hormonal monitoring and serial sampling of cervical mucus.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Roma
      • Rome, Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ostetricia e Patologia Ostetrica
        • Contact:
        • Principal Investigator:
          • Tullio Ghi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • HEALTHY CONTROL

    • Women of 18-45 years old,
    • Use of the Billings Ovulation Method® for at least three months in the last three years
    • Proven fertility

  • STUDY COHORT

    • Women of 18-45 years old,
    • Women affected by unexplained infertility

Exclusion Criteria:

  • Virgo women
  • Women incapable of understanding and wanting
  • Women who have had sexual intercourse in the two days prior to cervical mucus sampling
  • Pregnancy, exclusive breastfeeding
  • Amenorrhea
  • Gynecological hormone ongoing therapies or suspended for less than three months
  • Cervico -vaginal infections
  • Psychiatric pathologies
  • Untreated/decompensated endocrine-metabolic disorders
  • Coagulopathies and renal pathologies under dialysis treatment
  • Refusal of informed consent
  • Previous, current or suspected oncological pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CERVICAL MUCUS ANALYSIS
Analysis of the characterization by infrared spectroscopy of cervical mucus and its variations during the different phases of the menstrual cycle in cases vs healthy controls groups
Diagnostic test: cervical mucus sampling
Monitoring of menstrual cycle will be conducted in the follicular, ovulatory and luteal phases during which cervical mucus, serum and urine samples will be collected and pelvic ultrasound scans performed (3-5 ultrasound scans/samples within the cycle).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization by infrared spectroscopy of cervical mucus
Time Frame: 1 month (3 time points within a menstrual cycle)
Analysis of the spectra as revealed using by infrared spectroscopy on samples of cervical mucus. Analysis of their variations during the different phases of the menstrual cycle in cases group vs healthy controls groups.
1 month (3 time points within a menstrual cycle)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Tullio Ghi, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

January 10, 2025

First Posted (Actual)

January 13, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7175

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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