Apical Pelvic Support in Infertility Patients

NCT ID: NCT04039009

Last Updated: 2019-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility, Female Pelvic Organ Prolapse Pelvic Floor Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Infertility patients

Infertility patients will be examined according to the pelvic organ prolapse quantification classification system during hysteroscopy.

Pelvic Organ Prolapse Quantification system

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Uludag University

OTHER

Sponsor Role lead

Responsible Party

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Adnan Orhan

Principal Investigator. Associate professor, Obstetrician and Gynecologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gurkan Uncu, Prof.

Role: STUDY_DIRECTOR

ULUDAG UNIVERSITY HOSPITAL BURSA TURKEY

Locations

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Uludag University Hospital, Department of Obstetrics and Gynecology

Bursa, Ozluce, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Adnan Orhan, M.D.

Role: CONTACT

+905056337102

Kemal Ozerkan, Prof.

Role: CONTACT

+905056337102

Facility Contacts

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Adnan Orhan, M.D.

Role: primary

+90 505 6337102

Isil Kasapoglu, M.D

Role: backup

+905305455848

References

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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.

Reference Type BACKGROUND
PMID: 18799443 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10942459 (View on PubMed)

Other Identifiers

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UU-MREC-2019-9/22

Identifier Type: -

Identifier Source: org_study_id

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