Health TrialsbyHealthPanel

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

ConditionsPsychological Experience in Fertility TreatmentHypogonadismTestosteron LevelsQuality of LifeSocial InteractionInfertile Males Comparied to Fertile Males
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorPeter Humaidan

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

PESA/TESA, Cancer, Sterilized males

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 2 trial groups
Group A: Infertile males
Group B: Fertile males

Trial outcomes

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

Comparison of data from questionnaire and blood test between two groups

Time frame
From the start of fertility treatment to registration of pregnancy test
3

Classification of the examined population into APHRODITE groups

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peter Humaidan

Lead sponsor

Regionshospitalet Viborg, Skive

Sponsor institution

Source ClinicalTrials.gov
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