Early Pregnancy LossSF-EPLNCT07646275
Surgical vs. Medical Abortion on Sexual Function After Early Pregnancy Loss
A study testing mifepristone and misoprostol and Vacuum Aspiration in people with Early Pregnancy Loss and Abortion, Spontaneous, run by Harran University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Early Pregnancy Loss, Abortion, Spontaneous, Miscarriage
- What is being tested?
- mifepristone and misoprostol and Vacuum Aspiration
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- - 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Harran University, Department of Gynecology and Obstetrics
Sanliurfa, Şanliurfa, 63200
About this study
Official 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
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.
Read the 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.
- Being tested
- mifepristone and misoprostol, Vacuum Aspiration
- Keywords
- abortion, sexual function, Female Sexual Function Index, FSFI, surgical abortion, medical abortion, pregnancy loss
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mifepristone and misoprostolDrug
Participants received 200 mg oral mifepristone under supervision at the clinic, followed by 800 µg misoprostol administered at home 24-48 hours later.
Vacuum AspirationProcedure or surgery
Participants underwent vacuum aspiration under local or general anesthesia in an operating room for early pregnancy loss at 6-12 weeks gestation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: mifepristone and misoprostol |
| Surgical Abortion | Active comparator | Participants underwent vacuum aspiration under local or general anesthesia in an operating room. Receives: Procedure: Vacuum Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-treatment) and 6 months post-abortion procedure
Secondary outcomes (6)
Change in FSFI - Desire Domain Score
Desire domain consists of 2 items assessing sexual desire and interest over the past 4 weeks. Domain score range: 1.2-6.0.
Measured: Baseline and 6 months
Change in FSFI - Arousal Domain Score
Arousal domain consists of 4 items assessing sexual excitement and arousal over the past 4 weeks. Domain score range: 0-6.0.
Measured: Baseline and 6 months
Change in FSFI - Orgasm Domain Score
Orgasm domain consists of 3 items assessing ability to achieve orgasm over the past 4 weeks. Domain score range: 0-6.0.
Measured: Baseline and 6 months
Change in FSFI - Lubrication Domain Score
Lubrication domain consists of 4 items assessing vaginal lubrication during sexual activity over the past 4 weeks. Domain score range: 0-6.0.
Measured: Baseline and 6 months
Change in FSFI - Pain Domain Score
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.
Measured: Baseline and 6 months
Change in FSFI - Satisfaction Domain Score
Satisfaction domain consists of 3 items assessing sexual satisfaction over the past 4 weeks. Domain score range: 0.8-6.0.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Apr 2025
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Pregnancy LossStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were allocated to surgical or medical abortion based on shared decision-making with their physician.
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer Tammo, MD, Harran University
- Investigators
- ömer tammo, Principal investigator, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646275
- Sponsor's protocol ID
- HRU-FSFI-2025-01
- Acronym
- SF-EPL
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07646275
- Acronym / sponsor ID
- SF-EPL / HRU-FSFI-2025-01
- Keywords
- abortion, sexual function, Female Sexual Function Index, FSFI, surgical abortion, medical abortion, pregnancy loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were allocated to surgical or medical abortion based on shared decision-making with their physician.
| Arm | Type | Receives |
|---|---|---|
| Medical Abortion | Active comparator | Drug: mifepristone and misoprostolParticipants received 200 mg oral mifepristone under supervision at the clinic, followed by 800 µg misoprostol administered at home 24-48 hours later. |
| Surgical Abortion | Active comparator | Procedure: Vacuum AspirationParticipants underwent vacuum aspiration under local or general anesthesia in an operating room. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- - 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mifepristone and misoprostolParticipants received 200 mg oral mifepristone under supervision at the clinic, followed by 800 µg misoprostol administered at home 24-48 hours later. | Drug | Medical Abortion |
| Vacuum AspirationParticipants underwent vacuum aspiration under local or general anesthesia in an operating room for early pregnancy loss at 6-12 weeks gestation. | Procedure or surgery | Surgical Abortion |
Primary outcome
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.
6 secondary outcomes
Change in FSFI - Desire Domain Score
Time frame: Baseline and 6 months
Change in FSFI - Arousal Domain Score
Time frame: Baseline and 6 months
Change in FSFI - Orgasm Domain Score
Time frame: Baseline and 6 months
Change in FSFI - Lubrication Domain Score
Time frame: Baseline and 6 months
Change in FSFI - Pain Domain Score
Time frame: Baseline and 6 months
Change in FSFI - Satisfaction Domain Score
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
Related trials for Early Pregnancy Loss
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
Not yet recruitingPhase 3
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Research on Equity in Abortion Care by TeleHealth
Abortion in First Trimester, Abortion Early
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ömer tammo principal investigator
Harran University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mifepristone and misoprostol and Vacuum Aspiration in people with Early Pregnancy Loss and Abortion, Spontaneous, run by Harran University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Female Sexual Function Index (FSFI) Total Score (time frame: Baseline (pre-treatment) and 6 months post-abortion procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.