The Effect of Assisted Reproductive Technology on Male Sexual Function.

April 5, 2020 updated by: ROY LAUTERBACH MD, Rambam Health Care Campus

The Correlation Between Assisted Reproductive Technology and Male Erectile Dysfunction.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Men participating in fertility will be recruited to a study involving filling erectile function questionnaires throughout fertility treatments, pregnancy and up to 1 year after birth. In addition, participants will be questioned regarding marital life, sexual intercourse frequency, medical history and treatments for erectile dysfunction in relevant cases. Thes control group will be comprised of male subjects who did not require fertility treatments to conceive.

Study Type

Observational

Enrollment (Actual)

734

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Healthcare Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Male patients participating in fertility treatments.

Description

Inclusion Criteria:

  • Participation in fertility treatments.

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fertility treatments
Men participating in fertility treatments.
Other: Questionnaire and personal interviews.
Questionnaire and personal interviews.
Spontaneous pregnancy
Men whose wives conceived spontaneously.
Other: Questionnaire and personal interviews.
Questionnaire and personal interviews.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in International index of erectile function score
Time Frame: From recruitment up to 3 years.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual intercourse rate.
Time Frame: From recruitment up to 3 years.
Sexual intercourse rate as measured by the average monthly intercourse rate.
From recruitment up to 3 years.
Use of phospho-di-esterase 5 inhibitors
Time Frame: From recruitment up to 3 years.
Use of phospho-di-esterase 5 inhibitors as measured by the number of men using this medication.
From recruitment up to 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

April 5, 2020

First Submitted That Met QC Criteria

April 5, 2020

First Posted (Actual)

April 8, 2020

Study Record Updates

Last Update Posted (Actual)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 5, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0102-17-RMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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