NMR Metabolomics Study of Follicular Fluid of Oncological Patients

Metabolomics of Follicular Fluids in Patients Undergoing PMA

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.

Study Overview

• Status: Completed
• Conditions: Woman With Cancer Resorting Fertility Preservation
• Intervention / Treatment: Procedure: oocytes retrieval

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Italy
  • Potenza, Italy, 85100
    • Angela Ostuni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

oncological patients with pathological diagnosis resorting fertility preservation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy subjects; 10 subjects	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.
oncological patients; 10 subjects	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: San Carlo Public Hospital, Potenza, Italy
• Investigators: Principal Investigator: Maria Antonietta MACM Castiglione Morelli, Professor, University of Basilicata studies; Principal Investigator: Assunta Iuliano, MD, San Carlo Public Hospital, Potenza

Publications and helpful links

General Publications

• Castiglione Morelli MA, Iuliano A, Schettini SCA, Petruzzi D, Ferri A, Colucci P, Viggiani L, Cuviello F, Ostuni A. NMR metabolomics study of follicular fluid in women with cancer resorting to fertility preservation. J Assist Reprod Genet. 2018 Nov;35(11):2063-2070. doi: 10.1007/s10815-018-1281-7. Epub 2018 Aug 1.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: September 21, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 22, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: NMR Metabolomics Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No