NCT02431884

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 1, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

8.2 years

First QC Date

April 23, 2015

Last Update Submit

November 11, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Specimen bank for future clinical research studies

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

    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.

Study Arms (1)

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;

Procedure: collect body fluids/tissues & med history

Interventions

collect tissues/fluids \& history

Also known as: disorders of the ovaries, uterus, endocrine, endometrium
body fluids/tissues & history

Eligibility Criteria

Age8 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • females of childbearing potential experiencing reproductive endocrinology related problems.

You may not qualify if:

  • male or female not of childbearing potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional One Health Ob-Gyn Clinic

Memphis, Tennessee, 38103, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A portion of blood/tissue specimens that will be generated during the participants office visit or surgery.

MeSH Terms

Interventions

Endomet

Study Officials

  • Laura Detti, M.D.

    Associate Professor, UTennessee Health Science Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2015

First Posted

May 1, 2015

Study Start

January 1, 2012

Primary Completion

March 25, 2020

Study Completion

March 25, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations