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

NCT07546435 | Recruiting

• 1 other identifier: Male infertility
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Questionnaire of male experience of involvement in fertility treatment

  From 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 questionaire

  From the start of fertility treatment to registration of pregnancy test

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

  From the start of fertility treatment to registration of pregnancy test

Secondary Outcomes (3)

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

  From 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 quality

  From the start of fertility treatment to registration of pregnancy test

• Classification of the examined population into APHRODITE groups

  From the start of fertility treatment to end of study

Study Arms (2)

Infertile males

Males with reduced semen quality according to WHO 2021 6th edition

Fertile males

Males normal semen quality according to WHO 2021 6th edition

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male patients of infertile couples initiating fertility treatment. Both male with normal sperm parametres and male with reduced sperm parametres

You may qualify if:

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

You may not qualify if:

• PESA/TESA, Cancer, Sterilized males

Sponsors & Collaborators

• Peter Humaidan: lead

Study Sites (1)

Regionshospitalet

Skive, Midt Jylland, 7800, Denmark

RECRUITING

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 22, 2026
• Study Start: February 13, 2026
• Primary Completion (Estimated): January 15, 2029
• Study Completion (Estimated): January 15, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)