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NCT Number: NCT06771401

Identification of Biomarkers in Cervical Mucus

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.

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Key information

Conditions

Cervical Mucus Dysfunction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ostetricia e Patologia Ostetrica

Rome, Roma, 00168, Italy

Location status: Recruiting

Location contact

Tullio Ghi

CONTACT

[email protected]

Tullio Ghi

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cervical mucus sampling

Diagnostic Test

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).

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tullio Ghi

CONTACT

[email protected]

+390630155701

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: IBISCUS

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 13, 2025
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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