InfertilityINFEXONCT04539392
Assessment of the Sexuality of the Infertile Couple
An observational study of Infertility, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Questionnaires on sexuality
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2022to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 80 heterosexual infertile couples (according to the WHO definition) followed at the Nîmes University Hospital in the Urology / Gynecology departments.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Infertility
- Being tested
- Questionnaires on sexuality
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires on sexualityOther
Panel of questionnaires assessing sexuality, relationship satisfaction, and body image
| Study group | Role | What they receive |
|---|---|---|
| Infertile couple | Not described Receives: Other: Questionnaires on sexuality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 month after ovarian ponction (end of MAP)
Sexuality of the male of the couple
Male Sexual Health Questionnaire
Measured: 2 weeks after inclusion (start of MAP)
Sexuality of the male of the couple
Male Sexual Health Questionnaire
Measured: 1 month after ovarian ponction (end of MAP)
Ejactulation of the male of the couple
Premature Ejaculation Profile
Measured: 2 weeks after inclusion (start of MAP)
Ejactulation of the male of the couple
Premature Ejaculation Profile
Measured: 1 month after ovarian ponction (end of MAP)
Secondary outcomes (8)
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
Measured: 1 month after ovarian ponction (end of MAP)
Sexuality of the male of the couple
Male Sexual Health Questionnaire
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 1 month after ovarian ponction (end of MAP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start28 Jun 2022
- Primary completionNov 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie Huberlant, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539392
- Sponsor's protocol ID
- NIMAO/2019-2/SH-01
- Acronym
- INFEXO
- Status last verified
- Nov 2025
- First submitted
- 31 Aug 2020
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Sexuality of the Infertile Couple: Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04539392
- Acronym / sponsor ID
- INFEXO / NIMAO/2019-2/SH-01
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infertile couple | – | Other: Questionnaires on sexuality |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 80 heterosexual infertile couples (according to the WHO definition) followed at the Nîmes University Hospital in the Urology / Gynecology departments.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires on sexualityPanel of questionnaires assessing sexuality, relationship satisfaction, and body image | Other | Infertile couple |
Primary outcome
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
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
Sexuality of the male of the couple
Time frame: 2 weeks after inclusion (start of MAP)
Male Sexual Health Questionnaire
Sexuality of the male of the couple
Time frame: 1 month after ovarian ponction (end of MAP)
Male Sexual Health Questionnaire
Ejactulation of the male of the couple
Time frame: 2 weeks after inclusion (start of MAP)
Premature Ejaculation Profile
Ejactulation of the male of the couple
Time frame: 1 month after ovarian ponction (end of MAP)
Premature Ejaculation Profile
8 secondary outcomes
Sexuality of the female of the couple
Time frame: 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)
Body satisfaction and global self-perception of both members of the couple
Time frame: 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)
Relationship satisfaction of both members of the couple
Time frame: 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)
Self-esteem of both members of the couple
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphanie Huberlant principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexuality of the female of the couple (time frame: 2 weeks after inclusion (start of MAP)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.