Identification of Biomarkers in Cervical Mucus

Not Applicable

Not yet recruiting

• Conditions: Cervical Mucus Dysfunction; Infertility, Female

• Registration Number: NCT06771401
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-06
• Status Verified: 2025-01
• Study Start: 2025-01-10
• Study First Submitted QC: 2025-01-10
• Last Update Submitted: 2025-01-10
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Primary Completion: 2026-07-10
• Study Completion: 2028-01-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Characterization by infrared spectroscopy of cervical mucus	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.