Identification of Biomarkers in Cervical Mucus

Recruiting now · Not applicable

Conditions studied: Cervical Mucus Dysfunction, Infertility, Female

In brief

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.

Key facts

Study ID

NCT06771401

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

24

Starts

2026-03-10

Expected to finish

2027-03-31

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ostetricia e Patologia Ostetrica — Rome, Roma, Italy (enrolling)

Full record on ClinicalTrials.gov

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