Clinical trial NCT04101981: NMR Metabolomics Study of Follicular Fluid of Oncological Patients
Official title: Metabolomics of Follicular Fluids in Patients Undergoing PMA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Woman With Cancer Resorting Fertility Preservation
Lead sponsor: San Carlo Public Hospital, Potenza, Italy
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: oncological patients with pathological diagnosis resorting fertility preservation

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.

Eligibility criteria: 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.

Primary outcomes:
measure: follicular fluid metabolites of patients with neoplasia
timeFrame: NMR spectroscopy was performed immediately after oocyte retrieval
Secondary outcomes:
measure: to define the existence of cancer-specific metabolic profiles
timeFrame: NMR spectroscopy was performed immediately after oocyte retrieval
Other outcomes:
Locations:
city: Potenza
country: Italy
facility: Angela Ostuni
Study officials:
affiliation: University of Basilicata studies
name: Maria Antonietta MACM Castiglione Morelli, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: San Carlo Public Hospital, Potenza
name: Assunta Iuliano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.