- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07646275
Surgical vs. Medical Abortion on Sexual Function After Early Pregnancy Loss (SF-EPL)
June 9, 2026 updated by: Omer Tammo, MD, Harran University
Surgical Abortion for Early Pregnancy Loss is Associated With Greater Short-Term Decline in Sexual Function Compared to Medical Abortion: A Prospective Comparative Study
This study compares the medium-term effects of surgical and medical abortion on sexual function in women who have experienced early pregnancy loss (6-12 weeks gestation).
A total of 86 women (45 medical abortion, 41 surgical abortion) were followed for 6 months.
Sexual function was measured using the Female Sexual Function Index (FSFI) before treatment and at 6 months after the procedure.
The surgical abortion group showed a significant decline in total FSFI score at 6 months compared to baseline, with decreases observed in all six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain.
The medical abortion group showed no significant change in total FSFI score.
Between-group comparison at 6 months revealed significantly lower total FSFI scores in the surgical group compared to the medical group.
These findings suggest that surgical abortion for early pregnancy loss is associated with a significant decline in sexual function that persists up to 6 months after the procedure, whereas medical abortion appears to have a neutral effect during the same period.
Due to the non-randomized design, these findings should be considered hypothesis-generating.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This prospective, comparative cohort study was conducted at Harran University Faculty of Medicine between April 2025 and January 2026.
Women aged 18-40 diagnosed with early pregnancy loss (6-12 weeks gestation) were allocated to surgical or medical abortion based on shared decision-making.
The Female Sexual Function Index (FSFI) was used to evaluate sexual function before treatment and at 6 months follow-up.
Statistical analyses were performed using non-parametric tests (Mann-Whitney U, Wilcoxon signed-rank) with Bonferroni correction.
Effect sizes (r) were calculated for all primary outcomes.
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Şanliurfa
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Sanliurfa, Şanliurfa, Turkey (Türkiye), 63200
- Harran University, Department of Gynecology and Obstetrics
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- - Diagnosis of early pregnancy loss (6-12 weeks gestation)
- Planned to undergo either surgical or medical abortion
- Age between 18 and 40 years
- Proficiency in speaking and reading Turkish
- Voluntary participation and provision of written informed consent
Exclusion Criteria:
- A known pre-existing diagnosis of sexual dysfunction (baseline FSFI total score ≤ 26.55)
- A documented history of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder)
- History of chronic pelvic pain conditions (e.g., endometriosis, vulvodynia) or any other chronic medical condition known to significantly affect sexual function (e.g., unmanaged diabetes mellitus, multiple sclerosis)
- Current use of medications that can impact sexual function (e.g., SSRIs, SNRIs, antipsychotics, antihypertensives)
- Insufficient communication ability, defined as difficulty understanding and speaking Turkish or having cognitive/communication impairments that would prevent reliable completion of the study questionnaires
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Medical Abortion
Participants received 200 mg oral mifepristone under supervision at the clinic, followed by 800 µg misoprostol administered at home 24-48 hours later.
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Participants received 200 mg oral mifepristone under supervision at the clinic, followed by 800 µg misoprostol administered at home 24-48 hours later.
|
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Active Comparator: Surgical Abortion
Participants underwent vacuum aspiration under local or general anesthesia in an operating room.
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Participants underwent vacuum aspiration under local or general anesthesia in an operating room for early pregnancy loss at 6-12 weeks gestation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Female Sexual Function Index (FSFI) Total Score
Time Frame: Baseline (pre-treatment) and 6 months post-abortion procedure
|
The FSFI is a 19-item, multidimensional self-report questionnaire assessing female sexual function over the past four weeks.
It evaluates six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain.
The total score is the sum of six domain scores (range 2-36).
Lower scores indicate worse sexual dysfunction.
A total score of ≤26.55 is the validated cutoff for female sexual dysfunction.
|
Baseline (pre-treatment) and 6 months post-abortion procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in FSFI - Desire Domain Score
Time Frame: Baseline and 6 months
|
Desire domain consists of 2 items assessing sexual desire and interest over the past 4 weeks.
Domain score range: 1.2-6.0.
|
Baseline and 6 months
|
|
Change in FSFI - Arousal Domain Score
Time Frame: Baseline and 6 months
|
Arousal domain consists of 4 items assessing sexual excitement and arousal over the past 4 weeks.
Domain score range: 0-6.0.
|
Baseline and 6 months
|
|
Change in FSFI - Orgasm Domain Score
Time Frame: Baseline and 6 months
|
Orgasm domain consists of 3 items assessing ability to achieve orgasm over the past 4 weeks.
Domain score range: 0-6.0.
|
Baseline and 6 months
|
|
Change in FSFI - Lubrication Domain Score
Time Frame: Baseline and 6 months
|
Lubrication domain consists of 4 items assessing vaginal lubrication during sexual activity over the past 4 weeks.
Domain score range: 0-6.0.
|
Baseline and 6 months
|
|
Change in FSFI - Pain Domain Score
Time Frame: Baseline and 6 months
|
Pain domain consists of 3 items assessing pain during vaginal penetration and sexual activity over the past 4 weeks.
Domain score range: 0-6.0.
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Baseline and 6 months
|
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Change in FSFI - Satisfaction Domain Score
Time Frame: Baseline and 6 months
|
Satisfaction domain consists of 3 items assessing sexual satisfaction over the past 4 weeks.
Domain score range: 0.8-6.0.
|
Baseline and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: ömer tammo, Harran University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2025
Primary Completion (Actual)
January 31, 2026
Study Completion (Actual)
January 31, 2026
Study Registration Dates
First Submitted
June 9, 2026
First Submitted That Met QC Criteria
June 9, 2026
First Posted (Actual)
June 12, 2026
Study Record Updates
Last Update Posted (Actual)
June 12, 2026
Last Update Submitted That Met QC Criteria
June 9, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Pregnancy Complications
- Abortion, Spontaneous
- Fatty Acids
- Lipids
- Surgical Procedures, Operative
- Biological Factors
- Polycyclic Compounds
- Steroids
- Fused-Ring Compounds
- Estrenes
- Estranes
- Urogenital Surgical Procedures
- Prostaglandins, Synthetic
- Prostaglandins
- Eicosanoids
- Fatty Acids, Unsaturated
- Autacoids
- Inflammation Mediators
- Dilatation and Curettage
- Curettage
- Gynecologic Surgical Procedures
- Prostaglandins E, Synthetic
- Misoprostol
- Mifepristone
- Vacuum Curettage
Other Study ID Numbers
- HRU-FSFI-2025-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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