NMR Metabolomics Study of Follicular Fluid of Oncological Patients

Woman With Cancer Resorting Fertility Preservation Clinical Trial

Official title:

Metabolomics of Follicular Fluids in Patients Undergoing PMA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04101981
• Other study ID #: NMR Metabolomics Study
• Status: Completed
• Start date: May 1, 2016
• Est. completion date: May 31, 2018

Study information

• Verified date: November 2020
• Source: San Carlo Public Hospital, Potenza, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Woman With Cancer Resorting Fertility Preservation

Intervention

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.

Locations

Country	Name	City	State
Italy	Angela Ostuni	Potenza

Sponsors (1)

Lead Sponsor	Collaborator
San Carlo Public Hospital, Potenza, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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