Apical Pelvic Support in Infertility Patients

Pelvic Organ Prolapse Clinical Trial

Official title:

Apical Pelvic Compartment Support in Infertility Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04039009
• Other study ID #: UU-MREC-2019-9/22
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: July 2019
• Source: Uludag University
• Contact: Adnan Orhan, M.D.
• Phone: +905056337102
• Email: dr.adnan.orhan[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: October 31, 2019
• Est. primary completion date: September 30, 2019
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Turkey	Uludag University Hospital, Department of Obstetrics and Gynecology	Bursa	Ozluce

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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