The Effect of Assisted Reproductive Technology on Male Sexual Function.

Erectile Dysfunction Clinical Trial

Official title:

The Correlation Between Assisted Reproductive Technology and Male Erectile Dysfunction.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04338087
• Other study ID #: 0102-17-RMB
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2020
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 734
• Est. completion date: March 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Participation in fertility treatments.

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Other:
• Questionnaire and personal interviews.
Questionnaire and personal interviews.

Locations

Country	Name	City	State
Israel	Rambam healthcare campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sexual intercourse rate.	Sexual intercourse rate as measured by the average monthly intercourse rate.	From recruitment up to 3 years.
Secondary	Use of phospho-di-esterase 5 inhibitors	Use of phospho-di-esterase 5 inhibitors as measured by the number of men using this medication.	From recruitment up to 3 years.