NCT07628660

Brief Summary

Endometrial sampling is a commonly performed gynecological procedure used for the diagnosis of abnormal uterine bleeding and endometrial abnormalities. Different anesthetic techniques may be used during the procedure, including sedo-analgesia and local anesthesia. The purpose of this prospective observational study is to evaluate whether the anesthetic technique used during endometrial sampling affects female sexual function one month after the procedure. Female sexual function will be assessed using the validated Female Sexual Function Index (FSFI) questionnaire. A total of 210 women undergoing endometrial sampling at Prof. Dr. Cemil Taşcıoğlu City Hospital will be enrolled. Participants will be assigned to groups according to the anesthetic technique used during their routine clinical care. FSFI scores obtained at the one-month follow-up visit will be compared between women who underwent the procedure under sedo-analgesia and those who received local anesthesia. Secondary analyses will include comparison of FSFI scores according to symptom status and histopathological diagnosis. The findings of this study may contribute to a better understanding of the impact of anesthetic techniques on postoperative sexual health and quality of life in women undergoing gynecological procedures.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Apr 2026May 2027

Study Start

First participant enrolled

April 15, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2027

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

June 1, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

Endometrial Sampling,Female Sexual Function Index,Sedo-Analgesia,Local Anesthesia,Abnormal Uterine Bleeding,Sexual Health

Outcome Measures

Primary Outcomes (1)

  • Female Sexual Function Index (FSFI) Score at 1 Month

    Assessment of female sexual function one month after endometrial sampling using the validated Female Sexual Function Index (FSFI) questionnaire. Total FSFI scores will be compared between patients undergoing endometrial sampling under sedo-analgesia and those undergoing the procedure under local anesthesia.

    1 Month After Endometrial Sampling

Secondary Outcomes (1)

  • FSFI Subdomain Scores at 1 Month

    1 Month After Endometrial Sampling

Other Outcomes (2)

  • FSFI Scores According to Histopathological Diagnosis

    1 Month After Endometrial Sampling

  • FSFI Scores According to Symptom Status

    1 Month After Endometrial Sampling

Study Arms (2)

Sedo-Analgesia Group

Patients undergoing endometrial sampling under intravenous sedo-analgesia as part of routine clinical care.

Local Anesthesia Group

Patients undergoing endometrial sampling under local anesthesia as part of routine clinical care.

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study is limited to individuals who identify as women, as the study evaluates female sexual function using the Female Sexual Function Index (FSFI) following endometrial sampling.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of women aged 18-60 years undergoing endometrial sampling for various gynecological indications at the Department of Obstetrics and Gynecology, Prof. Dr. Cemil Taşcıoğlu City Hospital. Participants receiving sedo-analgesia or local anesthesia as part of routine clinical care will be included. Female sexual function will be assessed one month after the procedure using the Female Sexual Function Index (FSFI), and subgroup analyses may be performed according to symptom status and histopathological diagnosis.

You may qualify if:

  • Female patients aged 18 to 60 years
  • Undergoing endometrial sampling at the Department of Obstetrics and Gynecology, Prof. Dr. Cemil Taşcıoğlu City Hospital
  • Undergoing the procedure under sedo-analgesia or local anesthesia as part of routine clinical practice
  • Attendance at the 1-month follow-up visit
  • Ability to complete the Female Sexual Function Index (FSFI) questionnaire

You may not qualify if:

  • Age younger than 18 years or older than 60 years
  • Presence of known chronic systemic disease
  • Incomplete clinical or follow-up data
  • Failure to attend the 1-month follow-up visit
  • Inability or unwillingness to complete the FSFI questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof.Dr.Cemil Taşcıoğlu City Hospital

Istanbul, 34384, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Yağmur ÖZKAN, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 5, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

May 15, 2027

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect participant confidentiality and in accordance with institutional and ethical regulations governing clinical research data.

Locations