NMR Metabolomics Study of Follicular Fluid of Oncological Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Metabolomics of Follicular Fluids in Patients Undergoing PMA

Conditions
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Woman With Cancer Resorting Fertility Preservation

Intervention / Treatment
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* Procedure: oocytes retrieval


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy subjects<br>10 subjects | Procedure: oocytes retrieval<br>* 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.<br>|
| oncological patients<br>10 subjects | Procedure: oocytes retrieval<br>* 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.<br>|

What is the study measuring?
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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 |