NCT04539392

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Jun 2022Sep 2026

First Submitted

Initial submission to the registry

August 31, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 28, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

3.3 years

First QC Date

August 31, 2020

Last Update Submit

November 14, 2025

Conditions

Infertility

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (8)

  • Sexuality of the female of the couple

    1 month after ovarian ponction (end of MAP)

  • Sexuality of the male of the couple

    1 month after ovarian ponction (end of MAP)

  • Body satisfaction and global self-perception of both members of the couple

    2 weeks after inclusion (start of MAP)

  • Body satisfaction and global self-perception of both members of the couple

    1 month after ovarian ponction (end of MAP)

  • Relationship satisfaction of both members of the couple

    2 weeks after inclusion (start of MAP)

  • +3 more secondary outcomes

Study Arms (1)

Infertile couple

Other: Questionnaires on sexuality

Interventions

Questionnaires on sexualityOTHER

Panel of questionnaires assessing sexuality, relationship satisfaction, and body image

Infertile couple

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

80 heterosexual infertile couples (according to the WHO definition) followed at the Nîmes University Hospital in the Urology / Gynecology departments.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nimes

Nîmes, France

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Stéphanie Huberlant

    CHU Nimes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 7, 2020

Study Start

June 28, 2022

Primary Completion

November 1, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

November 17, 2025

Record last verified: 2025-11

Locations

FR(1)