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Clinical Trials/NCT04539392
NCT04539392
Active, not recruiting
Not Applicable

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

Centre Hospitalier Universitaire de Nīmes1 site in 1 country60 target enrollmentJune 28, 2022
ConditionsInfertility

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
60
Locations
1
Primary Endpoint
Sexuality of the male of the couple
Status
Active, not recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 28, 2022
End Date
September 1, 2026
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

Eligibility Criteria

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 40 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

Outcomes

Primary Outcomes

Sexuality of the male of the couple

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

Male Sexual Health Questionnaire

Ejactulation of the male of the couple

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

Premature Ejaculation Profile

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

Secondary Outcomes

  • Sexuality of the female of the couple(1 month after ovarian ponction (end of MAP))
  • Relationship satisfaction of both members of the couple(1 month after ovarian ponction (end of MAP))
  • Self-esteem of both members of the couple(1 month after ovarian ponction (end of MAP))
  • Sexuality of the male of the couple(1 month after ovarian ponction (end of MAP))
  • Body satisfaction and global self-perception of both members of the couple(1 month after ovarian ponction (end of MAP))

Study Sites (1)

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