NMR Metabolomics Study of Follicular Fluid of Oncological Patients

Overview

Purpose: The purpose of this study was to evaluate the possible application of metabolomics to identify follicular fluid changes in cancer patients undergoing fertility preservation. Although metabolomics have been applied already in cancer studies, this is the first application on follicular fluid of cancer patients.

Methods: The investigators selected for the study 10 patients with breast cancer and lymphoma who resorted to oocyte cryopreservation to preserve fertility and 10 healthy women undergoing in vitro fertilization treatments. Follicular fluid was collected at the time of oocytes retrieval. Metabolomic analysis of follicular fluids was performed by 1H NMR spectroscopy in combination with multivariate analysis to interpret the spectral data. Univariate statistical analysis was applied to find correlations between patients' features and metabolites identified by NMR.

Full Title of Study: “Metabolomics of Follicular Fluids in Patients Undergoing PMA”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: December 31, 2017

Detailed Description

The purpose of this study was to evaluate the possible application of metabolomics to identify follicular fluid changes in cancer patients undergoing fertility preservation. Although metabolomics have been applied already in cancer studies, this is the first application on follicular fluid of cancer patients.

Methods: The investigators selected for the study 10 patients with breast cancer and lymphoma who resorted to oocyte cryopreservation to preserve fertility and 10 healthy women undergoing in vitro fertilization treatments. Follicular fluid was collected at the time of oocytes retrieval. Metabolomic analysis of follicular fluids was performed by 1H NMR spectroscopy in combination with multivariate analysis to interpret the spectral data. Univariate statistical analysis was applied to find correlations between patients' features and metabolites identified by NMR.

Interventions

  • Procedure: oocytes retrieval
    • The oocytes retrieval was performed after 34-36 hours from hCG administration . The collection of cumulus-oocyte complexes and FFs were performed via transvaginal ultrasound-guided aspiration with a needle of 18 gauge of diameter. The three major diameter follicles were identified by intraoperative ultrasound and FF of each follicle was collected in its own test tube.

Arms, Groups and Cohorts

  • healthy subjects
    • 10 subjects
  • oncological patients
    • 10 subjects

Clinical Trial Outcome Measures

Primary Measures

  • follicular fluid metabolites of patients with neoplasia
    • Time Frame: NMR spectroscopy was performed immediately after oocyte retrieval
    • identification by NMR spectroscopy of the metabolites present in the follicular fluid of woman

Secondary Measures

  • to define the existence of cancer-specific metabolic profiles
    • Time Frame: NMR spectroscopy was performed immediately after oocyte retrieval
    • to study by NMR spectroscopy of the existence of cancer-specific metabolic profiles present in the follicular fluid of woman resorting to fertility preservation

Participating in This Clinical Trial

Inclusion Criteria

  • all nulliparous patients who want to have offspring, with a cancer diagnosis obtained by histological examination and with a definitive staging of the disease.

Exclusion Criteria

  • patients with suspected cancer diagnosis without histological examination and complete staging and women suffering of any cancer that received neoadjuvant chemotherapy or radiation therapy prior to follicular fluid collection.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 38 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • San Carlo Public Hospital, Potenza, Italy
  • Provider of Information About this Clinical Study
    • Principal Investigator: Assunta Iuliano, MD, NMR metabolomics study of follicular fluid in woman with cancer resorting to fertility preservation – San Carlo Public Hospital, Potenza, Italy
  • Overall Official(s)
    • Maria Antonietta MACM Castiglione Morelli, Professor, Principal Investigator, University of Basilicata studies
    • Assunta Iuliano, Phd, Principal Investigator, San Carlo Public Hospital, Potenza

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