Endocrine Disorders of Female Reproductive SystemNCT02431884
Tissue Samples and Bodily Fluid Specimens Banking
An observational study of Endocrine Disorders of Female Reproductive System, run by University of Tennessee at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older, women only
- Conditions the study is for
- Endocrine Disorders of Female Reproductive System
- What is being tested?
- collect body fluids/tissues & med history
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 25 Mar 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: POPULATION: Patients identified among all women presenting to the reproductive endocrinology clinic.
Who may be able to join
- females of childbearing potential experiencing reproductive endocrinology related problems.
Who cannot join
- male or female not of childbearing potential
Trial locations and contacts
1 site in 1 country.
United States1 site
Regional One Health Ob-Gyn Clinic
Memphis, Tennessee, 38103
About this study
Official title: Tissue and Bodily Fluid Specimens From Women Presenting to the Reproductive Endocrinology Clinic
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.
Read the detailed description
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.
- Being tested
- collect body fluids/tissues & med history
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collect body fluids/tissues & med historyProcedure or surgery
Also called disorders of the ovaries, uterus, endocrine, endometrium
collect tissues/fluids \& history
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: Procedure: collect body fluids/tissues & med history |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specimen bank for future clinical research studies
Creation of a blood serum/tissue specimens bank for future clinical research studies.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startJan 2012
- Primary completion25 Mar 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine Disorders of Female Reproductive SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Detti, M.D., Principal investigator, Associate Professor, UTennessee Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431884
- Sponsor's protocol ID
- 11-01629-XP
- Status last verified
- Nov 2020
- First submitted
- 23 Apr 2015
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue and Bodily Fluid Specimens From Women Presenting to the Reproductive Endocrinology Clinic
- ClinicalTrials.gov ID
- NCT02431884
- Acronym / sponsor ID
- 11-01629-XP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 1 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| body fluids/tissues & history | – | Procedure: collect body fluids/tissues & med historycollect body fluids/tissues \& med history from subjects with polycystic ovary syndrome(PCOS), congenital uterine malformations, endocrine malfunctions, endometriosis, and infertility; |
Who may qualify
- Ages
- 8 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- POPULATION: Patients identified among all women presenting to the reproductive endocrinology clinic.
Key inclusion criteria (1 listed)
- females of childbearing potential experiencing reproductive endocrinology related problems.
Key exclusion criteria (1 listed)
- male or female not of childbearing potential
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collect body fluids/tissues & med historyAlso: disorders of the ovaries, uterus, endocrine, endometriumcollect tissues/fluids \& history | Procedure or surgery | body fluids/tissues & history |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Detti, M.D. principal investigator
Associate Professor, UTennessee Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocrine Disorders of Female Reproductive System, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020; AzTrials last refreshed its copy on 29 Oct 2026.