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RecruitingNCT07864935LIFEUpdated Oct 8, 2026

Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction

An observational study in Sexual Health Quality of Life, Infertile Patients and Assisted Reproduction, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 8, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
240
Ages
18 Years and older
Sex
All
01

Study 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.

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).

02

Conditions studied

  • Sexual Health Quality of Life
  • Infertile Patients
  • Assisted Reproduction
03

In context

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 215 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Fertile and infertile couples attending the Urology Department and the MAR service

Inclusion criteria

  • Sexually active (at least 2 intercourses/week)
  • Patients who have signed the informed consent form

Exclusion criteria

Exclusion Criteria:

  • Conditions that may affect the sexual function (induratio penis plastica, hypogonadism, genital lichen planus, dyspareunia)
  • Psychiatric/depressive conditions
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
240 participants (estimated)
Patient registry
No

Groups and cohorts

  • group 1

    infertile men

  • group 2 control

    fertile men

  • group 3

    infertile women

  • group 4 control

    fertile women

06

What researchers measure

Primary outcomes

  1. Men sexual health

    Differences in the Sexual Satisfaction Index (ISS) score between infertile men undergoing homologous vs. heterologous fertilization

    Time frame: Day 1

Secondary outcomes

  1. Women sexual health

    Differences in the Sexual Satisfaction Index (ISS) score between infertile women undergoing homologous vs. heterologous fertilization

    Time frame: Day 1

  2. 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

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
    Mirano, 20122, Italy
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07864935
Lead sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Responsible party
Luca Boeri (Principal Investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico) — Principal investigator
First posted
Oct 8, 2026
Start date
Aug 1, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Jan 30, 2028 (estimated)
Last update
Oct 8, 2026

Study contacts

Luca Boeri, MD, PhD
Contact
LUCA.BOERI@POLICLINICO.MI.IT
+390255034501

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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