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NCT Number: NCT07646275

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

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.

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Key information

Conditions

Early Pregnancy Loss Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Miscarriage Pregnancy Complications Pregnancy, Unwanted Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Harran University, Department of Gynecology and Obstetrics

Sanliurfa, Şanliurfa, 63200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Harran University

Other

Registry information

Official study title

Surgical Abortion for Early Pregnancy Loss is Associated With Greater Short-Term Decline in Sexual Function Compared to Medical Abortion: A Prospective Comparative Study

Acronym: SF-EPL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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