RecruitingNot ApplicableNCT06771401

Identification of Biomarkers in Cervical Mucus

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


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

24 participants

Start Date

Mar 10, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria7

  • 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 Criteria12

  • 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

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Interventions

DIAGNOSTIC_TESTcervical 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).


Locations(1)

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

Rome, Roma, Italy

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NCT06771401


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