Clinical trial NCT04539392: Assessment of the Sexuality of the Infertile Couple
Official title: Assessment of the Sexuality of the Infertile Couple: Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80 heterosexual infertile couples (according to the WHO definition) followed at the Nîmes University Hospital in the Urology / Gynecology departments.

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.


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 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

Primary outcomes:
measure: Sexuality of the female of the couple
timeFrame: 2 weeks after inclusion (start of MAP)
measure: Sexuality of the female of the couple
timeFrame: 1 month after ovarian ponction (end of MAP)
measure: Sexuality of the male of the couple
timeFrame: 2 weeks after inclusion (start of MAP)
measure: Sexuality of the male of the couple
timeFrame: 1 month after ovarian ponction (end of MAP)
measure: Ejactulation of the male of the couple
timeFrame: 2 weeks after inclusion (start of MAP)
measure: Ejactulation of the male of the couple
timeFrame: 1 month after ovarian ponction (end of MAP)
Secondary outcomes:
measure: Sexuality of the female of the couple
timeFrame: 1 month after ovarian ponction (end of MAP)
measure: Sexuality of the male of the couple
timeFrame: 1 month after ovarian ponction (end of MAP)
measure: Body satisfaction and global self-perception of both members of the couple
timeFrame: 2 weeks after inclusion (start of MAP)
measure: Body satisfaction and global self-perception of both members of the couple
timeFrame: 1 month after ovarian ponction (end of MAP)
measure: Relationship satisfaction of both members of the couple
timeFrame: 2 weeks after inclusion (start of MAP)
measure: Relationship satisfaction of both members of the couple
timeFrame: 1 month after ovarian ponction (end of MAP)
measure: Self-esteem of both members of the couple
timeFrame: 2 weeks after inclusion (start of MAP)
measure: Self-esteem of both members of the couple
timeFrame: 1 month after ovarian ponction (end of MAP)
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Stéphanie Huberlant
role: PRINCIPAL_INVESTIGATOR
References: