Identification of Biomarkers in Cervical Mucus (IBISCUS)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Cervical Mucus Dysfunction; Infertility, Female

Treatments: Diagnostic Test: cervical mucus sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT06771401

7175

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

CERVICAL MUCUS ANALYSIS

Other group

Description:

Analysis of the characterization by infrared spectroscopy of cervical mucus and its variations during the different phases of the menstrual cycle in cases vs healthy controls groups

Treatment:

Diagnostic Test: cervical mucus sampling