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Completed

NCT Number: NCT05688228

Voluntary Interruption of Pregnancy on Women's Sexuality

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU Bordeaux

Bordeaux, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patient (≥ 18 years)
  • Patient performing a medical or surgical abortion
  • Patient with health insurance
  • No opposition to participation in the study

Exclusion criteria

  • 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.

Treatment and study plan

Questionnaire

Other

Female Sexual Function Index (FSFI) and self-administrative questionnaires on sexuality just after abortion and repeated at 1, 3 and 6 months

Primary outcomes

  1. 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

Secondary outcomes

  1. Marital status

    Time frame: Baseline

    single, couple, married

  2. Number of sexual partners in the last 12 months

    Time frame: Baseline

    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

  3. Number of sexual partners in the whole life

    Time frame: Baseline

    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

  4. Number of sexual partners in the last 4 weeks

    Time frame: Baseline

    Number of sexual partners via self-questionnaire : 0, 1, from 2 to 5, up to 5

  5. Frequency of sexual activity in the last month before pregnancy discovery

    Time frame: Baseline, Month 1, Month 3, Month 6

    < 1 /month ; from 1 from 3 /month ; 1 /week ; twice /week ; 3 or more times /week

  6. Existence of physical violence in the whole life

    Time frame: Baseline

    binary variable (yes/no)

  7. Existence of psychological violence in the whole life

    Time frame: Baseline

    binary variable (yes/no)

  8. Existence of sexual violence in the whole life

    Time frame: Baseline

    binary variable (yes/no)

  9. Existence of psychological symptoms before pregnancy's discovery

    Time frame: Baseline

    asthenia, sadness, anxiety, guilt, none

  10. Existence of psychological symptoms in the last month

    Time frame: Month 1, Month 3, Month 6

    asthenia, sadness, anxiety, guilt, none

  11. Existence of sexual difficulties since pregnancy's discovery

    Time frame: Baseline

    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

  12. Sexual activity the last month

    Time frame: Month 1, Month 3, Month 6

    Decreased sexual activity (fear of another pregnancy, waiting to start contraception, conflict with partner after abortion, other reason), Not concerned about decreased sexual activity

  13. Contraception in the last month

    Time frame: Month 1, Month 3, Month 6

    none, removal/cycles, condoms, pill, intrauterine devic, implant, ring/patch, other

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Description of the Evolution of Women's Sexuality After a Voluntary Interruption of Pregnancy

Acronym: VTOPSimpact

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 18, 2023
Registry last updated
May 8, 2024

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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