NMR Metabolomics Study of Follicular Fluid of Oncological Patients

Completed

• Conditions: Woman With Cancer Resorting Fertility Preservation
• Interventions: Procedure: oocytes retrieval

• Registration Number: NCT04101981
• Lead Sponsor: San Carlo Public Hospital, Potenza, Italy

Brief Summary

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.

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.

Study Timeline

• Study Start: 2016-05-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-05-31
• Study First Submitted: 2018-07-27
• Study First Submitted QC: 2019-09-21
• Study First Posted: 2019-09-24
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-22
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy subjects	oocytes retrieval	10 subjects
oncological patients	oocytes retrieval	10 subjects

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
to define the existence of cancer-specific metabolic profiles	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

Trial Locations

Locations (1)

Angela Ostuni; 🇮🇹 Potenza, Italy