ClinicalTrials.gg
Status unknownNCT04941690Updated Jul 9, 2021

Erectile Dysfunction, Psychological Disorders, and Sexual Performance Among Men Seeking Medical Help for Fertility

An observational study in Erectile Dysfunction, Sexual Dysfunction and Premature Ejaculation, sponsored by The First Hospital of Jilin University. Status unknown at 1 site in China. Open to male participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-07-09.

Sponsored by The First Hospital of Jilin University · Observational

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
1,000
Ages
20 Years and older
Sex
Male
01

Study 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. 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.

02

Conditions studied

  • Erectile Dysfunction
  • Sexual Dysfunction
  • Premature Ejaculation
  • Infertile Men
  • Fertile Men
  • Wife's Miscarriage
03

In context

Erectile Dysfunction

701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 130 across 125 observational studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

The First Hospital of Jilin University is the lead sponsor of 185 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

men seeking medical help for preconception tests, infertility, and recurrent miscarriage of their wives

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 form.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Men seen for preconception physicals

    Ready to conceive, i.e. not having contraception and not having children for less than 1 year

    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

    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

    Other: A questionnaire method was used.

Interventions

  • OtherA 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12-26-2021

07

Study locations

1 of 1 sites recruiting
  • Center for Reproductive Medicine and Center for Prenatal Diagnosis, Jilin University First Hospital
    Changchun, Jilin 130021, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04941690
Responsible party
Yu xiaowei (Clinical Professor, Center for Reproductive Medicine and Center for Prenatal Diagnosis, The First Hospital of Jilin University) — Principal investigator
First posted
Jun 28, 2021
Start date
Jun 26, 2021
Primary completion
Dec 2021 (estimated)
Completion
Mar 2022 (estimated)
Last update
Jul 9, 2021

Study contacts

Qun Wang, MD
Contact
wangqunjlu@jlu.edu.cn
+8618088680820

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion