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

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.

Study Overview

• Status: Recruiting
• Conditions: Sexual Dysfunction; Erectile Dysfunction; Premature Ejaculation; Infertile Men; Fertile Men; Wife's Miscarriage
• Intervention / Treatment: Other: A questionnaire method was used.

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Qun Wang, MD; Phone Number: +8618088680820; Email: wangqunjlu@jlu.edu.cn

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • Center for Reproductive Medicine and Center for Prenatal Diagnosis, Jilin University First Hospital
      • Contact: Qun Wang, MD; Phone Number: +8618088680820; Email: wangqunjlu@jlu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 informed consent form.

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.; 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.
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.; 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.
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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12-26-2021

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 26, 2021
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): March 1, 2022

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (ACTUAL): June 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2021
• Last Update Submitted That Met QC Criteria: July 6, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Mental Disorders; Erectile Dysfunction; Premature Ejaculation; Abortion, Spontaneous
• Other Study ID Numbers: 21K064-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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