NCT04338087

Brief Summary

Men participating in assisted reproductive technology treatments will be recruited to a study involving filling erectile function questionnaires throughout fertility treatments, pregnancy and up to 1 year after birth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
734

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

3 years

First QC Date

April 5, 2020

Last Update Submit

April 5, 2020

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Changes in International index of erectile function score

    Changes in International index of erectile function score with a possible score ranging from 0 to 75. The higher the score, the better erectile function is.

    From recruitment up to 3 years.

Secondary Outcomes (2)

  • Sexual intercourse rate.

    From recruitment up to 3 years.

  • Use of phospho-di-esterase 5 inhibitors

    From recruitment up to 3 years.

Study Arms (2)

Fertility treatments

Men participating in fertility treatments.

Other: Questionnaire and personal interviews.

Spontaneous pregnancy

Men whose wives conceived spontaneously.

Other: Questionnaire and personal interviews.

Interventions

Questionnaire and personal interviews.OTHER

Questionnaire and personal interviews.

Fertility treatmentsSpontaneous pregnancy

Eligibility Criteria

Age18 Years - 60 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male patients participating in fertility treatments.

You may qualify if:

  • Participation in fertility treatments.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam healthcare campus

Haifa, Israel

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Roy Lauterbach, MD

    Rambam healthcare campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 5, 2020

First Posted

April 8, 2020

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Study Completion

March 1, 2020

Last Updated

April 8, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)