Assessment of the Sexuality of the Infertile Couple

Infertility Clinical Trial

— INFEXO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04539392
• Other study ID #: NIMAO/2019-2/SH-01
• Status: Recruiting
• Start date: June 28, 2022
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Stéphanie Huberlant
• Phone: 04.66.68.34.69
• Email: stephanie.huberlant[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Questionnaires on sexuality
Panel of questionnaires assessing sexuality, relationship satisfaction, and body image

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexuality of the female of the couple	Female sexual function index: The total score is between 2 and 36 with sexual dysfunction indicated for scores below 26.55	2 weeks after inclusion (start of MAP)
Primary	Sexuality of the female of the couple	Female sexual function index: The total score is between 2 and 36 with sexual dysfunction indicated for scores below 26.55	1 month after ovarian ponction (end of MAP)
Primary	Sexuality of the male of the couple	Male Sexual Health Questionnaire	2 weeks after inclusion (start of MAP)
Primary	Sexuality of the male of the couple	Male Sexual Health Questionnaire	1 month after ovarian ponction (end of MAP)
Primary	Ejactulation of the male of the couple	Premature Ejaculation Profile	2 weeks after inclusion (start of MAP)
Primary	Ejactulation of the male of the couple	Premature Ejaculation Profile	1 month after ovarian ponction (end of MAP)
Secondary	Sexuality of the female of the couple	Female sexual function index: The total score is between 2 and 36 with sexual dysfunction indicated for scores below 26.55	1 month after ovarian ponction (end of MAP)
Secondary	Sexuality of the male of the couple	Male Sexual Health Questionnaire	1 month after ovarian ponction (end of MAP)
Secondary	Body satisfaction and global self-perception of both members of the couple	Questionnaire de satisfaction corporelle et de perception globale de soi (QSCPGS): total score ranges from -100 to +100.	2 weeks after inclusion (start of MAP)
Secondary	Body satisfaction and global self-perception of both members of the couple	Questionnaire de satisfaction corporelle et de perception globale de soi (QSCPGS): total score ranges from -100 to +100.	1 month after ovarian ponction (end of MAP)
Secondary	Relationship satisfaction of both members of the couple	Dyadic Adjustment Scale-16 Distress if score less than 92 and without distress if the score is higher than 107	2 weeks after inclusion (start of MAP)
Secondary	Relationship satisfaction of both members of the couple	Dyadic Adjustment Scale-16 Distress if score less than 92 and without distress if the score is higher than 107	1 month after ovarian ponction (end of MAP)
Secondary	Self-esteem of both members of the couple	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.	2 weeks after inclusion (start of MAP)
Secondary	Self-esteem of both members of the couple	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.	1 month after ovarian ponction (end of MAP)