NCT06771401 Identification of Biomarkers in Cervical Mucus
| NCT ID | NCT06771401 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Cervical Mucus Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-03-10 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2026-03-10 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Tullio Ghi
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06771401 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Cervical Mucus Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06771401 currently recruiting?
Yes, NCT06771401 is actively recruiting participants. Contact the research team at tullio.ghi@policlinicogemelli.it for enrollment information.
Where is the NCT06771401 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06771401 clinical trial?
NCT06771401 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Tullio Ghi at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 24 participants.