Apical Pelvic Support in Infertility Patients

Sponsor

Uludag University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04039009

Collaborator

(none)

1,100

Enrollment

Location

Anticipated Duration (Months)

110.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female Pelvic Organ Prolapse Pelvic Floor Disorders	Diagnostic Test: Pelvic Organ Prolapse Quantification system

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 Design

Study Type:

Observational

Anticipated Enrollment :

1100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Apical Pelvic Compartment Support in Infertility Patients

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Sep 30, 2019

Anticipated Study Completion Date :

Oct 31, 2019

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Stages of the pelvic organ prolapse [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.