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OpenTrials
Completed

NCT Number: NCT02431884

Tissue Samples and Bodily Fluid Specimens Banking

The purpose of this study is to collect a portion of blood/tissue specimens that will be generated during the participants office visit or surgery. The investigators are asking whether a small portion of the specimen/s could be set aside and banked for future research purposes. Data originating from participants will be gathered and analyzed in research studies that will help understanding various medical conditions such as polycystic ovary syndrome (PCOS), congenital uterine malformations, endocrine malfunctions, endometriosis, and infertility.

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Key information

Conditions

Endocrine Disorders of Female Reproductive System

Age range

8 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Regional One Health Ob-Gyn Clinic

Memphis, Tennessee, 38103, United States

About this study

PURPOSE: Women present to the Reproductive Endocrinology clinic with different concerns. These may involve conditions such as pelvic pain, endometriosis, Mullerian anomalies, polycystic ovary syndrome, abnormal uterine bleeding, menopausal symptoms, or infertility. Understanding the meaning of different biologic markers in their blood serum or tissues could help advancing the medical knowledge in the different conditions.

RATIONALE: To understand the meaning of different biologic markers in the patients' blood serum or tissue samples.

POPULATION: Patients identified among all women presenting to the reproductive endocrinology clinic.

Patients may undergo endometrial biopsy or surgery to evaluate their condition. In these instances, the investigators will ask the patients whether a small portion of their specimen/s could be collected and banked for future research purposes.

DESIGN: Prospective blood/tissue collection.

PROCEDURES: A small portion of the patient's blood or tissue specimen collected at the time of a medically indicated blood draw or surgical procedure will be collected and banked for future research purposes. Sample collection will be performed on existing specimens, once the specimens have been obtained for medical indications. No additional procedures will be performed on the patients for research purposes only.

OUTCOME MEASURES: Creation of a blood serum/tissue specimens bank for future clinical research studies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • females of childbearing potential experiencing reproductive endocrinology related problems.

Exclusion criteria

  • male or female not of childbearing potential

Treatment and study plan

collect body fluids/tissues & med history

Procedure

collect tissues/fluids & history

Other names: disorders of the ovaries, uterus, endocrine, endometrium

Primary outcomes

  1. Specimen bank for future clinical research studies

    Time frame: The samples collected during the clinical visit will be preserved and maintained as frozen specimens until the research is performed, which may occur from: within 1 year, and up to 24 years after collection.

    Creation of a blood serum/tissue specimens bank for future clinical research studies.

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Registry information

Official study title

Tissue and Bodily Fluid Specimens From Women Presenting to the Reproductive Endocrinology Clinic

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
May 1, 2015
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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