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The Effect of Assisted Reproductive Technology on Male Sexual Function.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04338087
Recruitment Status : Completed
First Posted : April 8, 2020
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
ROY LAUTERBACH MD, Rambam Health Care Campus

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.

Condition or disease Intervention/treatment
Erectile Dysfunction Other: Questionnaire and personal interviews.

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.

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Study Type : Observational
Actual Enrollment : 734 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Correlation Between Assisted Reproductive Technology and Male Erectile Dysfunction.
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Sexual intercourse rate. [ Time Frame: From recruitment up to 3 years. ]
    Sexual intercourse rate as measured by the average monthly intercourse rate.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male patients participating in fertility treatments.
Criteria

Inclusion Criteria:

  • Participation in fertility treatments.

Exclusion Criteria:

  • None.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04338087


Locations
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Israel
Rambam healthcare campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Roy Lauterbach, MD Rambam healthcare campus
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Responsible Party: ROY LAUTERBACH MD, Principal Investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT04338087    
Other Study ID Numbers: 0102-17-RMB
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders