NCT04039009

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

August 2, 2019

Status Verified

July 1, 2019

Enrollment Period

9 months

First QC Date

July 28, 2019

Last Update Submit

July 30, 2019

Conditions

Infertility, FemalePelvic Organ ProlapsePelvic Floor Disorders

Keywords

Pelvic organ prolapseInfertilityApical pelvic support

Outcome Measures

Primary Outcomes (1)

  • Stages of the pelvic organ prolapse

    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

Study Arms (1)

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

Interventions

Pelvic Organ Prolapse Quantification systemDIAGNOSTIC_TEST

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.

Infertility patients

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients examined for female infertility will be included in the study.
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population is the patients examined for female infertility.

You may qualify if:

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

You may not qualify if:

  • Malignity
  • Patients who become pregnant during infertility assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uludag University Hospital, Department of Obstetrics and Gynecology

Bursa, Ozluce, 16059, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311.

    PMID: 18799443BACKGROUND

  • Swift SE. The distribution of pelvic organ support in a population of female subjects seen for routine gynecologic health care. Am J Obstet Gynecol. 2000 Aug;183(2):277-85. doi: 10.1067/mob.2000.107583.

    PMID: 10942459BACKGROUND

MeSH Terms

Conditions

Infertility, FemalePelvic Organ ProlapsePelvic Floor DisordersInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPregnancy ComplicationsMale Urogenital Diseases

Study Officials

  • Gurkan Uncu, Prof.

    ULUDAG UNIVERSITY HOSPITAL BURSA TURKEY

    STUDY DIRECTOR

Central Study Contacts

Adnan Orhan, M.D.

CONTACT

+905056337102dr.adnan.orhan@hotmail.com

Kemal Ozerkan, Prof.

CONTACT

+905056337102ozerkan@uludag.edu.tr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator. Associate professor, Obstetrician and Gynecologist

Study Record Dates

First Submitted

July 28, 2019

First Posted

July 31, 2019

Study Start

January 1, 2019

Primary Completion

September 30, 2019

Study Completion

October 31, 2019

Last Updated

August 2, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)