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Assessment of the Sexuality of the Infertile Couple

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04539392
Acronym
INFEXO
Enrollment
80
Registered
2020-09-07
Start date
2022-06-28
Completion date
2026-09-30
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Brief summary

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.

Interventions

OTHERQuestionnaires on sexuality

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

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sexuality of the female of the couple2 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
Sexuality of the male of the couple2 weeks after inclusion (start of MAP)Male Sexual Health Questionnaire
Ejactulation of the male of the couple2 weeks after inclusion (start of MAP)Premature Ejaculation Profile

Secondary

MeasureTime frameDescription
Relationship satisfaction of both members of the couple2 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
Sexuality of the female of the couple1 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
Self-esteem of both members of the couple2 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.
Sexuality of the male of the couple1 month after ovarian ponction (end of MAP)Male Sexual Health Questionnaire
Body satisfaction and global self-perception of both members of the couple2 weeks after inclusion (start of MAP)Questionnaire de satisfaction corporelle et de perception globale de soi (QSCPGS): total score ranges from -100 to +100.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026