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NCT Number: NCT04539392

Assessment of the Sexuality of the Infertile Couple

The study hypothesis is that infertile couples experience an impact of their sexuality impacted during the diagnostic process carried out as part of the medically assisted procreation assessment, and also by the announcement of the possible cause of the couple's infertility. It is also conceivable that a disorder of the couple's sexuality forms the origin of, or is a contributor to, infertility.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nimes

Nîmes, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Couple in which each of the two partners has signed the consent form which is presented separately and independently of their partner.
  • The patient must be a member or beneficiary of a health insurance plan
  • Heterosexual infertile couple (according to the WHO definition) monitored at the Nîmes University Hospital in the urology / gynecology departments.

Adult patient (≥18 years old) and under 43 years old for women, 60 years old for men

Exclusion criteria

  • The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
  • One member of the couple refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • Patient without good level of written and spoken French

Treatment and study plan

Questionnaires on sexuality

Other

Panel of questionnaires assessing sexuality, relationship satisfaction, and body image

Primary outcomes

  1. Sexuality of the female of the couple

    Time frame: 2 weeks after inclusion (start of MAP)

    Female sexual function index: The total score is between 2 and 36 with sexual dysfunction indicated for scores below 26.55

  2. Sexuality of the female of the couple

    Time frame: 1 month after ovarian ponction (end of MAP)

    Female sexual function index: The total score is between 2 and 36 with sexual dysfunction indicated for scores below 26.55

  3. Sexuality of the male of the couple

    Time frame: 2 weeks after inclusion (start of MAP)

    Male Sexual Health Questionnaire

  4. Sexuality of the male of the couple

    Time frame: 1 month after ovarian ponction (end of MAP)

    Male Sexual Health Questionnaire

  5. Ejactulation of the male of the couple

    Time frame: 2 weeks after inclusion (start of MAP)

    Premature Ejaculation Profile

  6. Ejactulation of the male of the couple

    Time frame: 1 month after ovarian ponction (end of MAP)

    Premature Ejaculation Profile

Secondary outcomes

  1. Sexuality of the female of the couple

    Time frame: 1 month after ovarian ponction (end of MAP)

    Female sexual function index: The total score is between 2 and 36 with sexual dysfunction indicated for scores below 26.55

  2. Sexuality of the male of the couple

    Time frame: 1 month after ovarian ponction (end of MAP)

    Male Sexual Health Questionnaire

  3. Body satisfaction and global self-perception of both members of the couple

    Time frame: 2 weeks after inclusion (start of MAP)

    Questionnaire de satisfaction corporelle et de perception globale de soi (QSCPGS): total score ranges from -100 to +100.

  4. Body satisfaction and global self-perception of both members of the couple

    Time frame: 1 month after ovarian ponction (end of MAP)

    Questionnaire de satisfaction corporelle et de perception globale de soi (QSCPGS): total score ranges from -100 to +100.

  5. Relationship satisfaction of both members of the couple

    Time frame: 2 weeks after inclusion (start of MAP)

    Dyadic Adjustment Scale-16 Distress if score less than 92 and without distress if the score is higher than 107

  6. Relationship satisfaction of both members of the couple

    Time frame: 1 month after ovarian ponction (end of MAP)

    Dyadic Adjustment Scale-16 Distress if score less than 92 and without distress if the score is higher than 107

  7. Self-esteem of both members of the couple

    Time frame: 2 weeks after inclusion (start of MAP)

    Rosenberg self-esteem scale: The score is between 10 and 40. A score below 25 indicates very low self-esteem. A score between 25 and 31 indicates low self-esteem. A score between 31 and 34 indicates average self-esteem. A score between 34 and 39 indicates strong self-esteem. A score above 39 indicates very high self-esteem.

  8. Self-esteem of both members of the couple

    Time frame: 1 month after ovarian ponction (end of MAP)

    Rosenberg self-esteem scale: The score is between 10 and 40. A score below 25 indicates very low self-esteem. A score between 25 and 31 indicates low self-esteem. A score between 31 and 34 indicates average self-esteem. A score between 34 and 39 indicates strong self-esteem. A score above 39 indicates very high self-esteem.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Assessment of the Sexuality of the Infertile Couple: Prospective Cohort Study

Acronym: INFEXO

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Sep 7, 2020
Registry last updated
Nov 17, 2025

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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