NCT04941690

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

June 26, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

July 9, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

June 21, 2021

Last Update Submit

July 6, 2021

Conditions

Outcome Measures

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.

    12-26-2021

Study Arms (3)

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

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 infertilityMen seen for preconception physicalsMen who visited the clinic for their wives' miscarriage

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • , 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.

You may not qualify if:

  • , 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Reproductive Medicine and Center for Prenatal Diagnosis, Jilin University First Hospital

Changchun, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Erectile DysfunctionSexual Dysfunction, PhysiologicalPremature Ejaculation

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersEjaculatory Dysfunction

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, Center for Reproductive Medicine and Center for Prenatal Diagnosis

Study Record Dates

First Submitted

June 21, 2021

First Posted

June 28, 2021

Study Start

June 26, 2021

Primary Completion

December 1, 2021

Study Completion

March 1, 2022

Last Updated

July 9, 2021

Record last verified: 2021-07

Locations