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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sexually active (at least 2 intercourses/week)

Patients who have signed the informed consent form

Disqualifiers

Conditions that may affect the sexual function (induratio penis plastica, hypogonadism, genital lichen planus, dyspareunia)

Psychiatric/depressive conditions

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

240 Participants
are grouped into 4 trial groups
Group A: group 1
Group B: group 2 control
Group C: group 3
Group D: group 4 control

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.