Female Sexual DysfunctionFSFI-ENDONCT07628660
Assessment of Female Sexual Function Index (FSFI) Scores at 1 Month After Endometrial Sampling Performed Under Sedo-Analgesia or Local Anesthesia
An observational study of Female Sexual Dysfunction and Endometrial Sampling, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Female Sexual Dysfunction, Endometrial Sampling, Female Sexual Function Index (FSFI)
- Type of treatment
- Injection or infusion
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 15 May 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Prof.Dr.Cemil Taşcıoğlu City Hospital
Istanbul, 34384
Yağmur ÖZKAN, M.D., +90 5374318241, yagmurolmez92@hotmail.com
About this study
Official title: Evaluation of One-Month Female Sexual Function Index (FSFI) Scores in Women Undergoing Endometrial Sampling Under Sedo-Analgesia Versus Local Anesthesia
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.
Read more
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.
Read the detailed description
Endometrial sampling is a widely used gynecological procedure for the diagnosis and management of abnormal uterine bleeding and suspected endometrial pathology. The procedure may be performed under different anesthetic techniques, including sedo-analgesia and local anesthesia. Sedo-analgesia provides patient comfort through the administration of short-acting sedative and analgesic agents, whereas local anesthesia reduces procedural pain by blocking cervical nerve transmission. Both techniques are routinely used in clinical practice.
Sexual health is an important component of physical and psychological well-being. Procedure-related pain, anxiety, and postoperative discomfort may influence female sexual function and quality of life. However, limited data are available regarding the potential impact of anesthetic technique during endometrial sampling on subsequent sexual function.
The aim of this prospective observational cohort study is to evaluate whether undergoing endometrial sampling under sedo-analgesia or local anesthesia affects Female Sexual Function Index (FSFI) scores at one month after the procedure.
The study will be conducted at the Department of Obstetrics and Gynecology, Prof. Dr. Cemil Taşcıoğlu City Hospital, between April 2026 and April 2027. A total of 210 women aged 18 to 60 years undergoing endometrial sampling will be enrolled. Participants will be allocated into two cohorts according to the anesthetic technique used during routine clinical care:
Sedo-analgesia group (n=105) Local anesthesia group (n=105) Female sexual function will be evaluated at the one-month follow-up visit using the validated Female Sexual Function Index (FSFI), a 19-item questionnaire assessing six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain.
Demographic and clinical characteristics, including age, gravidity, parity, and abortion history, will also be recorded. FSFI scores will be compared between the two groups to determine whether anesthetic technique is associated with differences in postoperative sexual function.
Secondary analyses will include comparison of FSFI scores according to symptom status and histopathological diagnosis.
The results of this study may provide evidence regarding the influence of anesthetic management during gynecological procedures on female sexual health and may contribute to improving patient-centered perioperative care.
- Conditions
- Female Sexual Dysfunction, Endometrial Sampling, Female Sexual Function Index (FSFI), Abnormal Uterine Bleeding, Unspecified
- Keywords
- Endometrial Sampling,Female Sexual Function Index,Sedo-Analgesia,Local Anesthesia,Abnormal Uterine Bleeding,Sexual Health
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Month After Endometrial Sampling
Secondary outcomes (1)
FSFI Subdomain Scores at 1 Month
Assessment of FSFI subdomain scores, including desire, arousal, lubrication, orgasm, satisfaction, and pain, one month after endometrial sampling.
Measured: 1 Month After Endometrial Sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start15 Apr 2026
- Primary completion15 May 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yağmur ÖZKAN, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628660
- Sponsor's protocol ID
- CTCH-FSFI-2026-001
- Acronym
- FSFI-ENDO
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant confidentiality and in accordance with institutional and ethical regulations governing clinical research data.