INFEXO: Assessment of the Sexuality of the Infertile Couple

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04539392
Collaborator
(none)
60
1
15
4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaires on sexuality

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessment of the Sexuality of the Infertile Couple: Prospective Cohort Study
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Infertile couple

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

Outcome Measures

Primary Outcome Measures

  1. Sexuality of the female of the couple [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. Sexuality of the female of the couple [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

  3. Sexuality of the male of the couple [2 weeks after inclusion (start of MAP)]

    Male Sexual Health Questionnaire

  4. Sexuality of the male of the couple [1 month after ovarian ponction (end of MAP)]

    Male Sexual Health Questionnaire

  5. Ejactulation of the male of the couple [2 weeks after inclusion (start of MAP)]

    Premature Ejaculation Profile

  6. Ejactulation of the male of the couple [1 month after ovarian ponction (end of MAP)]

    Premature Ejaculation Profile

Secondary Outcome Measures

  1. Sexuality of the female of the couple [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

  2. Sexuality of the male of the couple [1 month after ovarian ponction (end of MAP)]

    Male Sexual Health Questionnaire

  3. Body satisfaction and global self-perception of both members of the couple [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.

  4. Body satisfaction and global self-perception of both members of the couple [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.

  5. Relationship satisfaction of both members of the couple [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

  6. Relationship satisfaction of both members of the couple [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

  7. Self-esteem of both members of the couple [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.

  8. Self-esteem of both members of the couple [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Nimes Nîmes France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Stéphanie Huberlant, CHU Nimes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT04539392
Other Study ID Numbers:
  • NIMAO/2019-2/SH-01
First Posted:
Sep 7, 2020
Last Update Posted:
Jun 3, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2022