NMR Metabolomics Study of Follicular Fluid of Oncological Patients

NCT04101981 | Completed DMC FDA Drug

• 1 other identifier: NMR Metabolomics Study
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Woman With Cancer Resorting Fertility Preservation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• to define the existence of cancer-specific metabolic profiles

  NMR spectroscopy was performed immediately after oocyte retrieval

Study Arms (2)

healthy subjects

10 subjects

Procedure: oocytes retrieval

oncological patients

10 subjects

Procedure: oocytes retrieval

Interventions

oocytes retrieval PROCEDURE

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.

healthy subjects; oncological patients

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

oncological patients with pathological diagnosis resorting fertility preservation

You may qualify if:

• all nulliparous patients who want to have offspring, with a cancer diagnosis obtained by histological examination and with a definitive staging of the disease.

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Carlo Public Hospital, Potenza, Italy: lead

Study Sites (1)

Angela Ostuni

Potenza, 85100, Italy

Location

Related 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.

  PMID: 30069850 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

follicular fluids

MeSH Terms

Interventions

Oocyte Retrieval

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Tissue and Organ Harvesting; Transplantation; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Maria Antonietta MACM Castiglione Morelli, Professor

  University of Basilicata studies

  PRINCIPAL INVESTIGATOR

• Assunta Iuliano, MD

  San Carlo Public Hospital, Potenza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NMR metabolomics study of follicular fluid in woman with cancer resorting to fertility preservation

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: September 24, 2019
• Study Start: May 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: May 31, 2018
• Last Updated: November 24, 2020

Record last verified: 2020-11

Locations

IT (1)