Apical Pelvic Support in Infertility Patients

July 30, 2019 updated by: Adnan Orhan, Uludag University

Apical Pelvic Compartment Support in Infertility Patients

This study aims to evaluate apical pelvic compartment support in infertility patients at the time of hysteroscopy. Apical pelvic compartment evaluation for pelvic organ prolapse will be performed in infertility patients undergoing hysteroscopy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The incidence of pelvic organ prolapse in the whole population has been demonstrated several times in previous studies. However, pelvic floor defects in young infertility patients are not known. In this study, a clinical pelvic floor assessment with the pelvic organ quantification system will be performed in infertility patients during standard physical examinations or hysteroscopy.

Study Type

Observational

Enrollment (Anticipated)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ozluce
      • Bursa, Ozluce, Turkey, 16059
        • Recruiting
        • Uludag University Hospital, Department of Obstetrics and Gynecology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study population is the patients examined for female infertility.

Description

Inclusion Criteria:

  • Ages between 18-45
  • Patients who cannot become pregnant despite regular sexual intercourse for more than one year

Exclusion Criteria:

  • Malignity
  • Patients who become pregnant during infertility assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infertility patients
Infertility patients will be examined according to the pelvic organ prolapse quantification classification system during hysteroscopy.
Diagnostic test: Pelvic Organ Prolapse Quantification system
The Pelvic Organ Prolapse Quantification system assessment tool measures nine anatomical points and distances in the vagina. The hymen is the reference point to which the other points are compared. The prolapsed organs are measured in centimeters to the hymen with an examination ruler.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stages of the pelvic organ prolapse
Time Frame: 2 minutes
Once the measurements are taken, the infertility patients are assigned to the corresponding POP-Q stage. Stage-0 is no prolapse. Stage-1 stands for the most distal portion of the prolapse is more than 1 cm above the level of the hymen. Stage-2 stands for the most distal prolapse is between 1 cm above and 1 cm below the hymen (at least one point is -1, 0, or +1). Stage-3: The most distal prolapse is more than 1 cm below the hymen but no further than 2 cm less than total vaginal length. Stage-4 stands for the complete vaginal eversion.
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uludag University

Investigators

  • Study Director: Gurkan Uncu, Prof., ULUDAG UNIVERSITY HOSPITAL BURSA TURKEY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

September 30, 2019

Study Completion (Anticipated)

October 31, 2019

Study Registration Dates

First Submitted

July 28, 2019

First Submitted That Met QC Criteria

July 28, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

July 30, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UU-MREC-2019-9/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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