The Effect of Assisted Reproductive Technology on Male Sexual Function.

• Sponsor: Rambam Health Care Campus (Other)
• Overall Status: Completed
• CT.gov ID: NCT04338087
• Collaborator: (none)
• Enrollment: 734
• Location: 1
• Actual Duration (Months): 37.9
• Patients Per Site Per Month: 19.3

Study Details

Study Description

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	Phase
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.

Study Design

• 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: Jan 1, 2017
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Sexual intercourse rate. [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 [From recruitment up to 3 years.]

   Use of phospho-di-esterase 5 inhibitors as measured by the number of men using this medication.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participation in fertility treatments.

Exclusion Criteria:

• None.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rambam healthcare campus	Haifa		Israel

Sponsors and Collaborators

• Rambam Health Care Campus

Investigators

• Principal Investigator: Roy Lauterbach, MD, Rambam healthcare campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ROY LAUTERBACH MD, Principal Investigator, Rambam Health Care Campus
• ClinicalTrials.gov Identifier: NCT04338087
• Other Study ID Numbers: 0102-17-RMB
• First Posted: Apr 8, 2020
• Last Update Posted: Apr 8, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Erectile Dysfunction

Study Results

No Results Posted as of Apr 8, 2020