Assessment of the Sexuality of the Infertile Couple (INFEXO)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Infertility
• Intervention / Treatment: Other: Questionnaires on sexuality

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

Study Locations

• France
  • Nîmes, France
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infertile couple	Other: Questionnaires on sexuality; Panel of questionnaires assessing sexuality, relationship satisfaction, and body image

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
Sexuality of the male of the couple	Male Sexual Health Questionnaire	2 weeks after inclusion (start of MAP)
Sexuality of the male of the couple	Male Sexual Health Questionnaire	1 month after ovarian ponction (end of MAP)
Ejactulation of the male of the couple	Premature Ejaculation Profile	2 weeks after inclusion (start of MAP)
Ejactulation of the male of the couple	Premature Ejaculation Profile	1 month after ovarian ponction (end of MAP)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Sexuality of the male of the couple	Male Sexual Health Questionnaire	1 month after ovarian ponction (end of MAP)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Stéphanie Huberlant, CHU Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2022
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: NIMAO/2019-2/SH-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No