Erectile DysfunctionNCT04941690
Erectile Dysfunction, Psychological Disorders, and Sexual Performance Among Men Seeking Medical Help for Fertility
An observational study of Erectile Dysfunction and Sexual Dysfunction, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
According to the World Health Organization (WHO) and the World Association for Sexual Health (WAS), sexual health is directly related to everyone's mental health and quality of life. Sexuality is innate to humans and is closely linked to their reproduction. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Erectile Dysfunction, Sexual Dysfunction, Premature Ejaculation
- What is being tested?
- A questionnaire method was used.
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2021to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: men seeking medical help for preconception tests, infertility, and recurrent miscarriage of their wives
Who may be able to join
- 1, men living with their wives and planning to have children; 2, men seeking medical help for preconception tests, infertility, and recurrent miscarriage of their wives; and 3, consenting to participate in the survey and signing an informed consent form.
Who cannot join
- 1, men with significant genital malformations, severe cardiovascular disease, stroke and mental disorders; 2, men who could not live with their female partners every day because they worked in different cities; 3, medical history of female partners with reproductive system abnormalities by gynecological examination.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Center for Reproductive Medicine and Center for Prenatal Diagnosis, Jilin University First Hospital
Changchun, Jilin, 130021
Qun Wang, MD, +8618088680820, wangqunjlu@jlu.edu.cn
About this study
Official title: Prevalence and Correlates of Erectile Dysfunction, Psychological Disorders, and Sexual Performance Among Men Seeking Medical Help for Preconception Test, Infertility and Wife Miscarriage
According to the World Health Organization (WHO) and the World Association for Sexual Health (WAS), sexual health is directly related to everyone's mental health and quality of life. Sexuality is innate to humans and is closely linked to their reproduction. Thus, a correlation between unmet fertility desires and sexual disorders can be observed in infertile couples. In fact, sexual intercourse itself will not be as natural in most cases and will preferentially occur during the "reproductive window". Thus, sexuality will be deprived of recreational and erotic activities, and sexuality will be used only for reproduction. For many men, sexual intercourse will become coercive, repetitive and mechanical, offering little emotion.
The interactions between infertility and wife recurrent miscarriage in sexuality are numerous and complex. Many men will perceive their infertility as a loss of masculinity and virility and may feel low self-esteem and depression, in addition, Decreased sperm quality may lead to anxiety in men, which may eventually lead to temporary Sexual Dysfunction (SD).Therefore, the need to identify SD and its severity is crucial for infertile men before receiving individualized male treatment.
Read the detailed description
In this study, a cross-sectional and clinical survey was conducted using a questionnaire method in the male department of the reproductive center of the First Hospital of Jilin University, China. The questionnaire included general population information, International Index of Sexual Function-5 (IIEF-5), Premature Ejaculation Diagnostic Tool (PEDT), General Anxiety Disorder-7 and CPSI. The inclusion criteria were: 1, men living with their wives and planning to have children; 2, men seeking medical help for preconception tests, infertility, and recurrent miscarriage of their wives; and 3, consenting to participate in the survey and signing an informed consent form. Exclusion criteria were: 1, men with significant genital malformations, severe cardiovascular disease, stroke and mental disorders; 2, men who could not live with their female partners every day because they worked in different cities; 3, medical history of female partners with reproductive system abnormalities by gynecological examination.
Investigators also collect relevant test results (if any) from the included patients during the visit. All patients routinely undergo a detailed male examination; for patients with preconception testing, the examination may include sperm quality, blood group, infection items (hepatitis B, hepatitis C, syphilis, AIDS), TORCH, etc; For infertile patients, only a sperm quality is performed in the first step; For patients whose wives have had recurrent miscarriages and are preparing to conceive again, the examination may include a detailed male examination, sperm quality, Chromosomes, blood group, infections (hepatitis B, C, syphilis, AIDS), TORCH, etc. If no abnormality is found, there is no follow-up examination, and if there is abnormality, further follow-up examination will be performed according to the process of Chinese Male Disease Diagnosis and Treatment Guidelines (2016). All consultations are in accordance with the process of Chinese Male Disease Diagnosis and Treatment Guidelines (2016). This study will not increase the physical and financial burden of the subjects.
- Conditions
- Erectile Dysfunction, Sexual Dysfunction, Premature Ejaculation, Infertile Men, Fertile Men, Wife's Miscarriage
- Being tested
- A questionnaire method was used.
- Medical subject headings
- Erectile Dysfunction, Sexual Dysfunction, Physiological, Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A questionnaire method was used.Other
The questionnaire included general population information, International Index of Sexual Function-5 (IIEF-5), Premature Ejaculation Diagnostic Tool (PEDT), General Anxiety Disorder-7 and CPSI.
| Study group | Role | What they receive |
|---|---|---|
| Men seen for preconception physicals | Ready to conceive, i.e. not having contraception and not having children for less than 1 year Receives: Other: A questionnaire method was used. | |
| Men seen for infertility | Couples who have not used contraception and have not had children for more than 1 year Receives: Other: A questionnaire method was used. | |
| Men who visited the clinic for their wives' miscarriage | Couples whose wives were previously pregnant but terminated the pregnancy due to fetal abortion, spontaneous abortion, biochemical pregnancy, fetal malformation or ectopic pregnancy Receives: Other: A questionnaire method was used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of sexual dysfunction among men seen for preconception testing, infertility, and wife miscarriage
Evaluation of the occurrence of sexual dysfunction among men seen for preconception testing, infertility, and wife miscarriage, A questionnaire method was used.
The questionnaire included general population information, International Index of Sexual Function-5 (IIEF-5), Premature Ejaculation Diagnostic Tool (PEDT), General Anxiety Disorder-7 and CPSI.
Measured: 12-26-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start26 Jun 2021
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu xiaowei, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941690
- Sponsor's protocol ID
- 21K064-001
- Status last verified
- Jul 2021
- First submitted
- 21 Jun 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Correlates of Erectile Dysfunction, Psychological Disorders, and Sexual Performance Among Men Seeking Medical Help for Preconception Test, Infertility and Wife Miscarriage
- ClinicalTrials.gov ID
- NCT04941690
- Acronym / sponsor ID
- 21K064-001
- Conditions
- Erectile Dysfunction, Sexual Dysfunction, Premature Ejaculation, Infertile Men, Fertile Men, Wife's Miscarriage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 26 Jun 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 28 Jun 2021 (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.
According to the World Health Organization (WHO) and the World Association for Sexual Health (WAS), sexual health is directly related to everyone's mental health and quality of life. Sexuality is innate to humans and is closely linked to their reproduction. Thus, a correlation between unmet fertility desires and sexual disorders can be observed in infertile couples. In fact, sexual intercourse itself will not be as natural in most cases and will preferentially occur during the "reproductive window". Thus, sexuality will be deprived of recreational and erotic activities, and sexuality will be used only for reproduction. For many men, sexual intercourse will become coercive, repetitive and mechanical, offering little emotion.
The interactions between infertility and wife recurrent miscarriage in sexuality are numerous and complex. Many men will perceive their infertility as a loss of masculinity and virility and may feel low self-esteem and depression, in addition, Decreased sperm quality may lead to anxiety in men, which may eventually lead to temporary Sexual Dysfunction (SD).Therefore, the need to identify SD and its severity is crucial for infertile men before receiving individualized male treatment.
Detailed description
In this study, a cross-sectional and clinical survey was conducted using a questionnaire method in the male department of the reproductive center of the First Hospital of Jilin University, China. The questionnaire included general population information, International Index of Sexual Function-5 (IIEF-5), Premature Ejaculation Diagnostic Tool (PEDT), General Anxiety Disorder-7 and CPSI. The inclusion criteria were: 1, men living with their wives and planning to have children; 2, men seeking medical help for preconception tests, infertility, and recurrent miscarriage of their wives; and 3, consenting to participate in the survey and signing an informed consent form. Exclusion criteria were: 1, men with significant genital malformations, severe cardiovascular disease, stroke and mental disorders; 2, men who could not live with their female partners every day because they worked in different cities; 3, medical history of female partners with reproductive system abnormalities by gynecological examination.
Investigators also collect relevant test results (if any) from the included patients during the visit. All patients routinely undergo a detailed male examination; for patients with preconception testing, the examination may include sperm quality, blood group, infection items (hepatitis B, hepatitis C, syphilis, AIDS), TORCH, etc; For infertile patients, only a sperm quality is performed in the first step; For patients whose wives have had recurrent miscarriages and are preparing to conceive again, the examination may include a detailed male examination, sperm quality, Chromosomes, blood group, infections (hepatitis B, C, syphilis, AIDS), TORCH, etc. If no abnormality is found, there is no follow-up examination, and if there is abnormality, further follow-up examination will be performed according to the process of Chinese Male Disease Diagnosis and Treatment Guidelines (2016). All consultations are in accordance with the process of Chinese Male Disease Diagnosis and Treatment Guidelines (2016). This study will not increase the physical and financial burden of the subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Men seen for preconception physicals | – | Other: A questionnaire method was used.Ready to conceive, i.e. not having contraception and not having children for less than 1 year |
| Men seen for infertility | – | Other: A questionnaire method was used.Couples who have not used contraception and have not had children for more than 1 year |
| Men who visited the clinic for their wives' miscarriage | – | Other: A questionnaire method was used.Couples whose wives were previously pregnant but terminated the pregnancy due to fetal abortion, spontaneous abortion, biochemical pregnancy, fetal malformation or ectopic pregnancy |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- men seeking medical help for preconception tests, infertility, and recurrent miscarriage of their wives
Key inclusion criteria (1 listed)
- 1, men living with their wives and planning to have children; 2, men seeking medical help for preconception tests, infertility, and recurrent miscarriage of their wives; and 3, consenting to participate in the survey and signing an informed consent form.
Key exclusion criteria (1 listed)
- 1, men with significant genital malformations, severe cardiovascular disease, stroke and mental disorders; 2, men who could not live with their female partners every day because they worked in different cities; 3, medical history of female partners with reproductive system abnormalities by gynecological examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A questionnaire method was used.The questionnaire included general population information, International Index of Sexual Function-5 (IIEF-5), Premature Ejaculation Diagnostic Tool (PEDT), General Anxiety Disorder-7 and CPSI. | Other | Men seen for infertility, Men seen for preconception physicals, Men who visited the clinic for their wives' miscarriage |
Primary outcome
Occurrence of sexual dysfunction among men seen for preconception testing, infertility, and wife miscarriage
Time frame: 12-26-2021
Evaluation of the occurrence of sexual dysfunction among men seen for preconception testing, infertility, and wife miscarriage, A questionnaire method was used. The questionnaire included general population information, International Index of Sexual Function-5 (IIEF-5), Premature Ejaculation Diagnostic Tool (PEDT), General Anxiety Disorder-7 and CPSI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 Erectile Dysfunction and Sexual Dysfunction, run by The First Hospital of Jilin University at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 9 Jul 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qun Wang, MD (+8618088680820, wangqunjlu@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of sexual dysfunction among men seen for preconception testing, infertility, and wife miscarriage (time frame: 12-26-2021). 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 9 Jul 2021.