Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction (LIFE)
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.
Studieoversikt
Status
Detaljert beskrivelse
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).
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Luca Boeri, MD, PhD
- Telefonnummer: +390255034501
- E-post: LUCA.BOERI@POLICLINICO.MI.IT
Studiesteder
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-
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Mirano, Italia, 20122
- Rekruttering
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
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Ta kontakt med:
- Luca Boeri, MD, PhD
- Telefonnummer: +390255034501
- E-post: LUCA.BOERI@POLICLINICO.MI.IT
-
Underetterforsker:
- Edgardo Somigliana, Prof., MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Fertile and infertile couples attending the Urology Department and the MAR service
Beskrivelse
Inclusion Criteria:
- Sexually active (at least 2 intercourses/week)
- Patients who have signed the informed consent form
Exclusion Criteria:
- Conditions that may affect the sexual function (induratio penis plastica, hypogonadism, genital lichen planus, dyspareunia)
- Psychiatric/depressive conditions
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: OTHER
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
group 1
infertile men |
|
group 2 control
fertile men |
|
group 3
infertile women |
|
group 4 control
fertile women |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Men sexual health
Tidsramme: 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). |
Day 1
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Women sexual health
Tidsramme: Day 1
|
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). |
Day 1
|
|
Couples sexual health
Tidsramme: Day 1
|
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). |
Day 1
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 7039
Legemiddel- og utstyrsinformasjon, studiedokumenter
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