The Effect of Assisted Reproductive Technology on Male Sexual Function.

Completed

• Conditions: Erectile Dysfunction
• Interventions: Other: Questionnaire and personal interviews.

• Registration Number: NCT04338087
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-03-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-05
• Study First Submitted QC: 2020-04-05
• Last Update Submitted: 2020-04-05
• Study First Posted: 2020-04-08
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 734

Inclusion Criteria

• Participation in fertility treatments.

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fertility treatments	Questionnaire and personal interviews.	Men participating in fertility treatments.
Spontaneous pregnancy	Questionnaire and personal interviews.	Men whose wives conceived spontaneously.

Primary Outcome Measures

Name	Time	Method
Changes in International index of erectile function score	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

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

Trial Locations

Locations (1)

Rambam healthcare campus; 🇮🇱 Haifa, Israel