CClinicalTrials.gg
Status unknownNCT04039009Updated Aug 2, 2019

Apical Pelvic Support in Infertility Patients

An observational study in Infertility, Female, Pelvic Organ Prolapse and Pelvic Floor Disorders, sponsored by Uludag University. Status unknown at 1 site in Turkey. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-08-02.

Sponsored by Uludag University · Observational

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,100
Ages
18 Years to 45 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Infertility, Female
  • Pelvic Organ Prolapse
  • Pelvic Floor Disorders

Keywords

  • Pelvic organ prolapse
  • Infertility
  • Apical pelvic support
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In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 1,100 is above the median of 200 across 714 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Uludag University is the lead sponsor of 141 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

The study population is the patients examined for female infertility.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Malignity
  • Patients who become pregnant during infertility assessment
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testPelvic 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.

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What researchers measure

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.

    Time frame: 2 minutes

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Study locations

1 of 1 sites recruiting
  • Uludag University Hospital, Department of Obstetrics and Gynecology
    Bursa, Ozluce 16059, Turkey
    Recruiting
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References and documents

Publications

  • 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. PubMed 18799443 ↗
  • 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. PubMed 10942459 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04039009
Lead sponsor
Uludag University
Responsible party
Adnan Orhan (Principal Investigator. Associate professor, Obstetrician and Gynecologist, Uludag University) — Principal investigator
First posted
Jul 31, 2019
Start date
Jan 1, 2019
Primary completion
Sep 30, 2019 (estimated)
Completion
Oct 31, 2019 (estimated)
Last update
Aug 2, 2019

Study contacts

Adnan Orhan, M.D.
Contact
dr.adnan.orhan@hotmail.com
+905056337102
Kemal Ozerkan, Prof.
Contact
ozerkan@uludag.edu.tr
+905056337102
Gurkan Uncu, Prof.
study director · ULUDAG UNIVERSITY HOSPITAL BURSA TURKEY

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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