Psychological Experience in Fertility TreatmentNCT07546435
Male Experiences With Intra Cytoplasmic Sperm Injection (ICSI) and Reduced Sperm Quality
An observational study of Psychological Experience in Fertility Treatment and Hypogonadism, run by Peter Humaidan at 1 site in Denmark.
Trial 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 … Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Psychological Experience in Fertility Treatment, Hypogonadism, Testosteron Levels
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Feb 2026to 15 Jan 2029
- How long will I take part?
- 4 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male patients of infertile couples initiating fertility treatment. Both male with normal sperm parametres and male with reduced sperm parametres
Who may be able to join
- ICSI treatment caused by reduced semen quality, language (danish)
Who cannot join
- PESA/TESA, Cancer, Sterilized males
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Regionshospitalet
Skive, Midt Jylland, 7800
Peter Humaidan PH Professior, Professor, +45 7844 5760, peter.humaidan@midt.rm.dk
Betina Boel Povlsen BBP Cheif Embryologist, Embryologist, betina.bp@rm.dk
About this study
Official title: 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.
- Conditions
- Psychological Experience in Fertility Treatment, Hypogonadism, Testosteron Levels, Quality of Life, Social Interaction, Infertile Males Comparied to Fertile Males
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire of male experience of involvement in fertility treatment
Measured: 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
Measured: From the start of fertility treatment to registration of pregnancy test
Correlation between male serum testosterone level and quality of life evaluated from questionnaire
Measured: 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
Measured: 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
Measured: From the start of fertility treatment to registration of pregnancy test
Classification of the examined population into APHRODITE groups
Measured: From the start of fertility treatment to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start13 Feb 2026
- Primary completion15 Jan 2029 (estimated)
- Study completion15 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological Experience in Fertility TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 4 Days
Sponsor and investigators
- Lead sponsor
- Peter Humaidan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Humaidan, Regionshospitalet Viborg, Skive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546435
- Sponsor's protocol ID
- Male infertility
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Male Experiences With Intra Cytoplasmic Sperm Injection (ICSI) and Reduced Sperm Quality - Have Anything Changed the Past 15 Years?
- ClinicalTrials.gov ID
- NCT07546435
- Acronym / sponsor ID
- Male infertility
- Conditions
- Psychological Experience in Fertility Treatment, Hypogonadism, Testosteron Levels, Quality of Life, Social Interaction, Infertile Males Comparied to Fertile Males
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Peter HumaidanUniversity, hospital or other
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- 15 Jan 2029 (estimated)
- Study completion
- 15 Jan 2029 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients of infertile couples initiating fertility treatment. Both male with normal sperm parametres and male with reduced sperm parametres
Key inclusion criteria (1 listed)
- ICSI treatment caused by reduced semen quality, language (danish)
Key exclusion criteria (1 listed)
- PESA/TESA, Cancer, Sterilized males
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Questionnaire of male experience of involvement in fertility treatment
Time frame: 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
Time frame: From the start of fertility treatment to registration of pregnancy test
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
3 secondary outcomes
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
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
Classification of the examined population into APHRODITE groups
Time frame: From the start of fertility treatment to end of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Experience in Fertility Treatment and Hypogonadism, run by Peter Humaidan at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire of male experience of involvement in fertility treatment (time frame: From the start of fertility treatment to registration of pregnancy test). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.