Surgical vs. Medical Abortion on Sexual Function After Early Pregnancy Loss

NCT07646275 | Completed

• 1 other identifier: HRU-FSFI-2025-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early Pregnancy Loss; Abortion, Spontaneous; Miscarriage; Pregnancy, Unwanted

Keywords

abortion; sexual function; Female Sexual Function Index; FSFI; surgical abortion; medical abortion; pregnancy loss

Outcome Measures

Primary Outcomes (1)

• Change in Female Sexual Function Index (FSFI) Total Score

  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 Outcomes (6)

• Change in FSFI - Desire Domain Score

  Baseline and 6 months

• Change in FSFI - Arousal Domain Score

  Baseline and 6 months

• Change in FSFI - Orgasm Domain Score

  Baseline and 6 months

• Change in FSFI - Lubrication Domain Score

  Baseline and 6 months

• Change in FSFI - Pain Domain Score

  Baseline and 6 months

Study Arms (2)

Medical Abortion

ACTIVE COMPARATOR

Participants received 200 mg oral mifepristone under supervision at the clinic, followed by 800 µg misoprostol administered at home 24-48 hours later.

Drug: mifepristone and misoprostol

Surgical Abortion

ACTIVE COMPARATOR

Participants underwent vacuum aspiration under local or general anesthesia in an operating room.

Procedure: Vacuum Aspiration

Interventions

Vacuum Aspiration PROCEDURE

Participants underwent vacuum aspiration under local or general anesthesia in an operating room for early pregnancy loss at 6-12 weeks gestation.

Surgical Abortion

mifepristone and misoprostol DRUG

Participants received 200 mg oral mifepristone under supervision at the clinic, followed by 800 µg misoprostol administered at home 24-48 hours later.

Medical Abortion

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Harran University, Department of Gynecology and Obstetrics

Sanliurfa, Şanliurfa, 63200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Mifepristone; Misoprostol; Vacuum Curettage

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Dilatation and Curettage; Curettage; Surgical Procedures, Operative; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• ömer tammo

  Harran University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Participants were allocated to surgical or medical abortion based on shared decision-making with their physician.

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start: April 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

TU (1)