Sexual Health Quality of LifeLIFENCT07864935
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
An observational study of Sexual Health Quality of Life and Infertile Patients, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Fertile and infertile couples attending the Urology Unit and the Assisted Reproductive Technology (ART) Service at our Foundation will be enrolled. As part of the standard of care, all couples will undergo both a gynecological evaluation and consultation and an andrological evaluation and consultation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sexual Health Quality of Life, Infertile Patients, Assisted Reproduction
- How many people
- 240 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2026to 30 Jan 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Fertile and infertile couples attending the Urology Department and the MAR service
Who may be able to join
- Sexually active (at least 2 intercourses/week)
- Patients who have signed the informed consent form
Who cannot join
- Conditions that may affect the sexual function (induratio penis plastica, hypogonadism, genital lichen planus, dyspareunia)
- Psychiatric/depressive conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Mirano, 20122
Luca Boeri, MD, PhD, +390255034501, LUCA.BOERI@POLICLINICO.MI.IT
Edgardo Somigliana, Prof., MD
About this study
Official title: A Retrospective and Prospective Study on the Impact of Infertility on the Sexual Sphere in Couples Undergoing Homologous and Heterologous Assisted Reproduction and in Fertile Controls
Fertile and infertile couples attending the Urology Unit and the Assisted Reproductive Technology (ART) Service at our Foundation will be enrolled. As part of the standard of care, all couples will undergo both a gynecological evaluation and consultation and an andrological evaluation and consultation.
In accordance with routine clinical practice, infertile couples will be asked during the consultation to complete validated self-administered questionnaires designed to assess the impact of infertility on their sexual function.
Read the detailed description
The aim of the study is to evaluate the impact of infertility on sexual function. The following validated questionnaires will be administered to both the study couples and the control group:
- All couples: Index of Sexual Satisfaction (ISS; 25 items; approximately 5 minutes to complete) and the Depression Anxiety Stress Scale-21 (DASS-21; 21 items; approximately 4 minutes to complete).
- Infertile couples only: Fertility Problem Inventory (FPI; 46 items; approximately 10 minutes to complete).
- All male participants: International Index of Erectile Function (IIEF; 15 items; approximately 4 minutes to complete).
- All female participants: Female Sexual Function Index (FSFI; 19 items; approximately 4 minutes to complete).
Questionnaire data will be collected from infertile couples undergoing homologous or heterologous assisted reproductive treatment. The control group will consist of couples attending the same outpatient clinic who have previously achieved at least one full-term pregnancy without the use of assisted reproductive technology (ART).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | infertile men | |
| group 2 control | fertile men | |
| group 3 | infertile women | |
| group 4 control | fertile women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Men sexual health
Differences in the Sexual Satisfaction Index (ISS) score between infertile men undergoing homologous vs. heterologous fertilization. ISS have a Total Score Range from 0 to 100 (higher scores mean higher levels of sexual dissatisfaction).
Measured: Day 1
Secondary outcomes (2)
Women sexual health
Differences in the Sexual Satisfaction Index (ISS) score between infertile women undergoing homologous vs. heterologous fertilization. ISS have a Total Score Range from 0 to 100 (higher scores mean higher levels of sexual dissatisfaction).
Measured: Day 1
Couples sexual health
Differences in the Sexual Satisfaction Index (ISS) score between subjects (both male and female) undergoing homologous or heterologous fertilization VS control of fertile couples. ISS have a Total Score Range from 0 to 100 (higher scores mean higher levels of sexual dissatisfaction).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Aug 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Health Quality of LifeStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Other
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Boeri, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864935
- Sponsor's protocol ID
- 7039
- Acronym
- LIFE
- Status last verified
- Nov 2026
- First submitted
- 28 Aug 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective and Prospective Study on the Impact of Infertility on the Sexual Sphere in Couples Undergoing Homologous and Heterologous Assisted Reproduction and in Fertile Controls
- ClinicalTrials.gov ID
- NCT07864935
- Acronym / sponsor ID
- LIFE / 7039
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 8 Oct 2026 (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.
Fertile and infertile couples attending the Urology Unit and the Assisted Reproductive Technology (ART) Service at our Foundation will be enrolled. As part of the standard of care, all couples will undergo both a gynecological evaluation and consultation and an andrological evaluation and consultation.
In accordance with routine clinical practice, infertile couples will be asked during the consultation to complete validated self-administered questionnaires designed to assess the impact of infertility on their sexual function.
Detailed description
The aim of the study is to evaluate the impact of infertility on sexual function. The following validated questionnaires will be administered to both the study couples and the control group:
- All couples: Index of Sexual Satisfaction (ISS; 25 items; approximately 5 minutes to complete) and the Depression Anxiety Stress Scale-21 (DASS-21; 21 items; approximately 4 minutes to complete).
- Infertile couples only: Fertility Problem Inventory (FPI; 46 items; approximately 10 minutes to complete).
- All male participants: International Index of Erectile Function (IIEF; 15 items; approximately 4 minutes to complete).
- All female participants: Female Sexual Function Index (FSFI; 19 items; approximately 4 minutes to complete).
Questionnaire data will be collected from infertile couples undergoing homologous or heterologous assisted reproductive treatment. The control group will consist of couples attending the same outpatient clinic who have previously achieved at least one full-term pregnancy without the use of assisted reproductive technology (ART).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –infertile men |
| group 2 control | – | –fertile men |
| group 3 | – | –infertile women |
| group 4 control | – | –fertile women |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Fertile and infertile couples attending the Urology Department and the MAR service
Key inclusion criteria (2 listed)
- Sexually active (at least 2 intercourses/week)
- Patients who have signed the informed consent form
Key exclusion criteria (2 listed)
- Conditions that may affect the sexual function (induratio penis plastica, hypogonadism, genital lichen planus, dyspareunia)
- Psychiatric/depressive conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Men sexual health
Time frame: Day 1
Differences in the Sexual Satisfaction Index (ISS) score between infertile men undergoing homologous vs. heterologous fertilization. ISS have a Total Score Range from 0 to 100 (higher scores mean higher levels of sexual dissatisfaction).
2 secondary outcomes
Women sexual health
Time frame: Day 1
Couples sexual health
Time frame: Day 1
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 6 Nov 2026.
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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.
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 Sexual Health Quality of Life and Infertile Patients, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. 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 Italy. 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?
Contact Luca Boeri, MD, PhD (+390255034501, LUCA.BOERI@POLICLINICO.MI.IT), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Men sexual health (time frame: Day 1). 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 6 Nov 2026.