NMR Metabolomics Study of Follicular Fluid of Oncological Patients

Sponsor

San Carlo Public Hospital, Potenza, Italy (Other)

Overall Status

Completed

CT.gov ID

NCT04101981

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Woman With Cancer Resorting Fertility Preservation	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.

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Metabolomics of Follicular Fluids in Patients Undergoing PMA

Actual Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

May 31, 2018

Arms and Interventions

Arm	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.

Arm

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 38 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Angela Ostuni	Potenza		Italy	85100

Sponsors and Collaborators

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

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Assunta Iuliano, MD, NMR metabolomics study of follicular fluid in woman with cancer resorting to fertility preservation, San Carlo Public Hospital, Potenza, Italy

ClinicalTrials.gov Identifier:

NCT04101981

Other Study ID Numbers:

NMR Metabolomics Study

First Posted:

Sep 24, 2019

Last Update Posted:

Nov 24, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 24, 2020