- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04539392
Assessment of the Sexuality of the Infertile Couple (INFEXO)
January 11, 2024 updated by: Centre Hospitalier Universitaire de Nīmes
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
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stéphanie Huberlant
- Phone Number: 04.66.68.34.69
- Email: stephanie.huberlant@chu-nimes.fr
Study Contact Backup
- Name: Cyrille Blion
- Phone Number: 04.66.68.32.30
- Email: cyrille.blion@chu-nimes.fr
Study Locations
-
-
-
Nîmes, France
- Recruiting
- CHU de Nimes
-
Principal Investigator:
- Cyrille BLION
-
Sub-Investigator:
- Marie Laure Tailland
-
Sub-Investigator:
- Sylvie NEVEU-RIPART
-
Sub-Investigator:
- Olivier POUGET
-
Sub-Investigator:
- Laurent WAGNER
-
Contact:
- Anissa Megzari
- Phone Number: 04.66.68.42.36
- Email: drc@chu-nimes.fr
-
Principal Investigator:
- Stéphanie HUBERLANT
-
Sub-Investigator:
- Stéphane DROUPY
-
Sub-Investigator:
- Marine Commissaire
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
60 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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Infertile couple
|
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
Time Frame: 2 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
|
2 weeks after inclusion (start of MAP)
|
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
|
1 month after ovarian ponction (end of MAP)
|
Sexuality of the male of the couple
Time Frame: 2 weeks after inclusion (start of MAP)
|
Male Sexual Health Questionnaire
|
2 weeks after inclusion (start of MAP)
|
Sexuality of the male of the couple
Time Frame: 1 month after ovarian ponction (end of MAP)
|
Male Sexual Health Questionnaire
|
1 month after ovarian ponction (end of MAP)
|
Ejactulation of the male of the couple
Time Frame: 2 weeks after inclusion (start of MAP)
|
Premature Ejaculation Profile
|
2 weeks after inclusion (start of MAP)
|
Ejactulation of the male of the couple
Time Frame: 1 month after ovarian ponction (end of MAP)
|
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
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
|
1 month after ovarian ponction (end of MAP)
|
Sexuality of the male of the couple
Time Frame: 1 month after ovarian ponction (end of MAP)
|
Male Sexual Health Questionnaire
|
1 month after ovarian ponction (end of MAP)
|
Body satisfaction and global self-perception of both members of the couple
Time Frame: 2 weeks after inclusion (start of MAP)
|
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
Time Frame: 1 month after ovarian ponction (end of MAP)
|
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
Time Frame: 2 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
|
2 weeks after inclusion (start of MAP)
|
Relationship satisfaction of both members of the couple
Time Frame: 1 month after ovarian ponction (end of MAP)
|
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
Time Frame: 2 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.
|
2 weeks after inclusion (start of MAP)
|
Self-esteem of both members of the couple
Time Frame: 1 month after ovarian ponction (end 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.
|
1 month after ovarian ponction (end of MAP)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stéphanie Huberlant, CHU Nimes
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 28, 2022
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
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 (Actual)
January 12, 2024
Last Update Submitted That Met QC Criteria
January 11, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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