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Male Experiences With Intra Cytoplasmic Sperm Injection (ICSI) and Reduced Sperm Quality

Male Experiences With Intra Cytoplasmic Sperm Injection (ICSI) and Reduced Sperm Quality - Have Anything Changed the Past 15 Years?

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07546435
Enrollment
400
Registered
2026-04-22
Start date
2026-02-13
Completion date
2029-01-15
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism, Infertile Males Comparied to Fertile Males, Psychological Experience in Fertility Treatment, Quality of Life, Social Interaction, Testosteron Levels

Brief summary

Several international studies indicate that men with reduced semen quality often feel overlooked in the context of fertility treatment. Men who undergo fertility treatment due to their own infertility, exhibit increased concern and experience more negative emotions such as loss, stigmatization, and low self-esteem - more so than men undergoing fertility treatment for other reasons. Since 2008, there has been limited research on the experiences of male patients with infertility in Denmark. Furthermore, there is generally very little knowledge regarding the testosterone levels (hypogonadism) of male infertile patients and its association with quality of life. Thus, there is a lack of updated insight into how infertile men experience their situation today. Additionally, the present study finds it relevant to examine whether men's needs and experiences in interactions with health professionals have changed over the past 15 years.

Interventions

None listed

Sponsors

Peter Humaidan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* ICSI treatment caused by reduced semen quality, language (danish)

Exclusion criteria

* PESA/TESA, Cancer, Sterilized males

Design outcomes

Primary

MeasureTime frame
Questionnaire of male experience of involvement in fertility treatmentFrom the start of fertility treatment to registration of pregnancy test
Change in patient-experience when compared to the 2008 study conducted at The University Clinic for Fertility, Regional Hospital Skive by using the same questionaireFrom the start of fertility treatment to registration of pregnancy test
Correlation between male serum testosterone level and quality of life evaluated from questionnaireFrom the start of fertility treatment to registration of pregnancy test

Secondary

MeasureTime frameDescription
Questionnarie about the prevalence of psychological and social burden i fertility treatmentFrom the start of fertility treatment to registration of pregnancy test
A comparison between men with reduced semen quality and men without reduced semen quality focusing on the prevalence of psychological and social burden, desire to communicate with health professionals, and serum testosterone level and life qualityFrom the start of fertility treatment to registration of pregnancy testComparison of data from questionnaire and blood test between two groups
Classification of the examined population into APHRODITE groupsFrom the start of fertility treatment to end of study

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026