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NCT Number: NCT07546435

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Regionshospitalet

Skive, Midt Jylland, 7800, Denmark

Location status: Recruiting

Location contact

Betina Boel Povlsen BBP Cheif Embryologist, Embryologist

CONTACT

[email protected]

Peter Humaidan PH Professior, Professor

CONTACT

[email protected]

+45 7844 5760

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • PESA/TESA, Cancer, Sterilized males

Treatment and study plan

Primary outcomes

  1. Questionnaire of male experience of involvement in fertility treatment

    Time frame: From the start of fertility treatment to registration of pregnancy test

  2. Change in patient-experience when compared to the 2008 study conducted at The University Clinic for Fertility, Regional Hospital Skive by using the same questionaire

    Time frame: From the start of fertility treatment to registration of pregnancy test

  3. Correlation between male serum testosterone level and quality of life evaluated from questionnaire

    Time frame: From the start of fertility treatment to registration of pregnancy test

Secondary outcomes

  1. Questionnarie about the prevalence of psychological and social burden i fertility treatment

    Time frame: From the start of fertility treatment to registration of pregnancy test

  2. 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 quality

    Time frame: From the start of fertility treatment to registration of pregnancy test

    Comparison of data from questionnaire and blood test between two groups

  3. Classification of the examined population into APHRODITE groups

    Time frame: From the start of fertility treatment to end of study

Sponsors and collaborators

Lead sponsor

Peter Humaidan

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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