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?

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Hypogonadism; Social Interaction; Psychological Experience in Fertility Treatment; Testosteron Levels; Infertile Males Comparied to Fertile Males

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• Denmark
  • Midt Jylland
    • Skive, Midt Jylland, Denmark, 7800
      • Recruiting
      • Regionshospitalet
      • Contact: Peter Humaidan PH Professior, Professor; Phone Number: +45 7844 5760; Email: peter.humaidan@midt.rm.dk
      • Contact: Betina Boel Povlsen BBP Cheif Embryologist, Embryologist; Email: betina.bp@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• PESA/TESA, Cancer, Sterilized males

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Comparison of data from questionnaire and blood test between two groups	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

Collaborators and Investigators

• Sponsor: Peter Humaidan

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2026
• Primary Completion (Estimated): January 15, 2029
• Study Completion (Estimated): January 15, 2029

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism
• Other Study ID Numbers: Male infertility

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No