AbortionVTOPSimpactNCT05688228
Voluntary Interruption of Pregnancy on Women's Sexuality
An observational study of Abortion, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The impact on sexuality has been less studied and there is no French study on this subject and the rare studies are contradictory. The aim of this study is to evaluate the impact of abortion (medical or surgical) on female sexuality, to look for a difference in the impact on sexuality according to the method used for… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abortion
- What is being tested?
- questionnaire
- How many people
- 209 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2023to 10 Feb 2024
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women performing a medical or surgical abortion
Who may be able to join
- Adult patient (≥ 18 years)
- Patient performing a medical or surgical abortion
- Patient with health insurance
- No opposition to participation in the study
Who cannot join
- Patient who does not speak French and/or is illiterate
- Patient under legal protection
- Patient unable to complete the study procedures (no internet connection, no smart phone or tablet)
- Patient with diagnosed psychiatric comorbidities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Description of the Evolution of Women's Sexuality After a Voluntary Interruption of Pregnancy
The impact on sexuality has been less studied and there is no French study on this subject and the rare studies are contradictory.
The aim of this study is to evaluate the impact of abortion (medical or surgical) on female sexuality, to look for a difference in the impact on sexuality according to the method used for the termination (medical or surgical) just after the procedure and at 1, 3 and 6 months and to look for risk factors and protective factors for the existence or occurrence of sexual dysfunction before and after abortion.
Read the detailed description
The medical consequences of abortion are low. However, there is an undeniable emotional and psychological impact on these women (40-45% of anxiety-type symptoms, approximately 20% of depressive symptoms after the discovery of the pregnancy and 30% of emotional disorders, particularly anxiety, in the month following the abortion).
The impact on sexuality has been less studied and there is no French study on this subject and the rare studies are contradictory.
The aim of this study is to evaluate the impact of voluntary termination of pregnancy (medical or surgical) on female sexuality, to look for a difference in the impact on sexuality according to the method used for the termination (medical or surgical) just after the procedure and at 1, 3 and 6 months and to look for risk factors and protective factors for the existence or occurrence of sexual dysfunction before and after a termination.
- Conditions
- Abortion
- Being tested
- questionnaire
- Keywords
- Abortion, Female sexuality, FSFI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Female Sexual Function Index (FSFI) and self-administrative questionnaires on sexuality just after abortion and repeated at 1, 3 and 6 months
| Study group | Role | What they receive |
|---|---|---|
| Abortion | Adult women performing a medical or surgical abortion Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with sexual dysfunction
Sexual dysfunction is assessed using the Female Sexual Function Index (FSFI) questionnaire, which takes into account several aspects of female sexuality: desire, arousal, lubrication, orgasm, satisfaction and pain. The threshold for differentiating between patients with and without sexual dysfunction is 26.55
Measured: Month 6
Secondary outcomes (13)
Marital status
single, couple, married
Measured: Baseline
Number of sexual partners in the last 12 months
Number of sexual partners via self-questionnaire : 1 ; from 2 to 5 ; from 6 to 10 ; from 11 to 15 ; from 16 to 20 ; up to 20
Measured: Baseline
Number of sexual partners in the whole life
Number of sexual partners via self-questionnaire : 1 ; from 2 to 5 ; from 6 to 10 ; from 11 to 15 ; from 16 to 20 ; up to 20
Measured: Baseline
Number of sexual partners in the last 4 weeks
Number of sexual partners via self-questionnaire : 0, 1, from 2 to 5, up to 5
Measured: Baseline
Frequency of sexual activity in the last month before pregnancy discovery
< 1 /month ; from 1 from 3 /month ; 1 /week ; twice /week ; 3 or more times /week
Measured: Baseline, Month 1, Month 3, Month 6
Existence of physical violence in the whole life
binary variable (yes/no)
Measured: Baseline
Existence of psychological violence in the whole life
binary variable (yes/no)
Measured: Baseline
Existence of sexual violence in the whole life
binary variable (yes/no)
Measured: Baseline
Existence of psychological symptoms before pregnancy's discovery
asthenia, sadness, anxiety, guilt, none
Measured: Baseline
Existence of psychological symptoms in the last month
asthenia, sadness, anxiety, guilt, none
Measured: Month 1, Month 3, Month 6
Existence of sexual difficulties since pregnancy's discovery
Decreased desire, arousal, lubrication, quantity or quality of orgasms, sexual satisfaction or relationship with the partner, appearance or increase of pain during sexual intercourse, no change in these different areas of sexuality
Measured: Baseline
Sexual activity the last month
Decreased sexual activity (fear of another pregnancy, waiting to start contraception, conflict with partner after abortion, other reason), Not concerned about decreased sexual activity
Measured: Month 1, Month 3, Month 6
Contraception in the last month
none, removal/cycles, condoms, pill, intrauterine devic, implant, ring/patch, other
Measured: Month 1, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start27 Feb 2023
- Primary completion10 Feb 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbortionStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688228
- Sponsor's protocol ID
- CHUBX 2022/71
- Acronym
- VTOPSimpact
- Status last verified
- May 2024
- First submitted
- 28 Dec 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Evolution of Women's Sexuality After a Voluntary Interruption of Pregnancy
- ClinicalTrials.gov ID
- NCT05688228
- Acronym / sponsor ID
- VTOPSimpact / CHUBX 2022/71
- Conditions
- Abortion
- Keywords
- Abortion, Female sexuality, FSFI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 18 Jan 2023 (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.
The impact on sexuality has been less studied and there is no French study on this subject and the rare studies are contradictory.
The aim of this study is to evaluate the impact of abortion (medical or surgical) on female sexuality, to look for a difference in the impact on sexuality according to the method used for the termination (medical or surgical) just after the procedure and at 1, 3 and 6 months and to look for risk factors and protective factors for the existence or occurrence of sexual dysfunction before and after abortion.
Detailed description
The medical consequences of abortion are low. However, there is an undeniable emotional and psychological impact on these women (40-45% of anxiety-type symptoms, approximately 20% of depressive symptoms after the discovery of the pregnancy and 30% of emotional disorders, particularly anxiety, in the month following the abortion).
The impact on sexuality has been less studied and there is no French study on this subject and the rare studies are contradictory.
The aim of this study is to evaluate the impact of voluntary termination of pregnancy (medical or surgical) on female sexuality, to look for a difference in the impact on sexuality according to the method used for the termination (medical or surgical) just after the procedure and at 1, 3 and 6 months and to look for risk factors and protective factors for the existence or occurrence of sexual dysfunction before and after a termination.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abortion | – | Other: questionnaireAdult women performing a medical or surgical abortion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women performing a medical or surgical abortion
Key inclusion criteria (4 listed)
- Adult patient (≥ 18 years)
- Patient performing a medical or surgical abortion
- Patient with health insurance
- No opposition to participation in the study
Key exclusion criteria (4 listed)
- Patient who does not speak French and/or is illiterate
- Patient under legal protection
- Patient unable to complete the study procedures (no internet connection, no smart phone or tablet)
- Patient with diagnosed psychiatric comorbidities.
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 |
|---|---|---|
| questionnaireFemale Sexual Function Index (FSFI) and self-administrative questionnaires on sexuality just after abortion and repeated at 1, 3 and 6 months | Other | Abortion |
Primary outcome
Number of patients with sexual dysfunction
Time frame: Month 6
Sexual dysfunction is assessed using the Female Sexual Function Index (FSFI) questionnaire, which takes into account several aspects of female sexuality: desire, arousal, lubrication, orgasm, satisfaction and pain. The threshold for differentiating between patients with and without sexual dysfunction is 26.55
13 secondary outcomes
Marital status
Time frame: Baseline
Number of sexual partners in the last 12 months
Time frame: Baseline
Number of sexual partners in the whole life
Time frame: Baseline
Number of sexual partners in the last 4 weeks
Time frame: Baseline
Frequency of sexual activity in the last month before pregnancy discovery
Time frame: Baseline, Month 1, Month 3, Month 6
Existence of physical violence in the whole life
Time frame: Baseline
Existence of psychological violence in the whole life
Time frame: Baseline
Existence of sexual violence in the whole life
Time frame: Baseline
Existence of psychological symptoms before pregnancy's discovery
Time frame: Baseline
Existence of psychological symptoms in the last month
Time frame: Month 1, Month 3, Month 6
Existence of sexual difficulties since pregnancy's discovery
Time frame: Baseline
Sexual activity the last month
Time frame: Month 1, Month 3, Month 6
Contraception in the last month
Time frame: Month 1, Month 3, Month 6
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 8 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abortion, run by University Hospital, Bordeaux at 1 site in France.
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 4 inclusion and 4 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 8 May 2024. 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 France. 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?
Number of patients with sexual dysfunction (time frame: Month 6). 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 8 May 2024.