Tissue Samples and Bodily Fluid Specimens Banking

NCT ID: NCT02431884

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2020-03-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endocrine Disorders of Female Reproductive System

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

body fluids/tissues & history

collect body fluids/tissues \& med history from subjects with polycystic ovary syndrome(PCOS), congenital uterine malformations, endocrine malfunctions, endometriosis, and infertility;

collect body fluids/tissues & med history

Intervention Type PROCEDURE

collect tissues/fluids \& history

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

collect body fluids/tissues & med history

collect tissues/fluids \& history

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

disorders of the ovaries, uterus, endocrine, endometrium

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* females of childbearing potential experiencing reproductive endocrinology related problems.

Exclusion Criteria

* male or female not of childbearing potential
Minimum Eligible Age

8 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laura Detti, M.D.

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, UTennessee Health Science Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Regional One Health Ob-Gyn Clinic

Memphis, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11-01629-XP

Identifier Type: -

Identifier Source: org_study_id