Erectile DysfunctionNCT04338087
The Effect of Assisted Reproductive Technology on Male Sexual Function.
An observational study of Erectile Dysfunction, run by Rambam Health Care Campus at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Questionnaire and personal interviews.
- How many people
- 734 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2017to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Study population: Male patients participating in fertility treatments.
Who may be able to join
- Participation in fertility treatments.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- Questionnaire and personal interviews.
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and personal interviews.Other
Questionnaire and personal interviews.
| Study group | Role | What they receive |
|---|---|---|
| Fertility treatments | Men participating in fertility treatments. Receives: Other: Questionnaire and personal interviews. | |
| Spontaneous pregnancy | Men whose wives conceived spontaneously. Receives: Other: Questionnaire and personal interviews. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From recruitment up to 3 years.
Secondary outcomes (2)
Sexual intercourse rate.
Sexual intercourse rate as measured by the average monthly intercourse rate.
Measured: From recruitment up to 3 years.
Use of phospho-di-esterase 5 inhibitors
Use of phospho-di-esterase 5 inhibitors as measured by the number of men using this medication.
Measured: From recruitment up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start1 Jan 2017
- Primary completion1 Jan 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 734 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROY LAUTERBACH MD, Rambam Health Care Campus
- Investigators
- Roy Lauterbach, MD, Principal investigator, Rambam healthcare campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338087
- Sponsor's protocol ID
- 0102-17-RMB
- Status last verified
- Apr 2020
- First submitted
- 5 Apr 2020
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Assisted Reproductive Technology and Male Erectile Dysfunction.
- ClinicalTrials.gov ID
- NCT04338087
- Acronym / sponsor ID
- 0102-17-RMB
- Conditions
- Erectile Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 734 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fertility treatments | – | Other: Questionnaire and personal interviews.Men participating in fertility treatments. |
| Spontaneous pregnancy | – | Other: Questionnaire and personal interviews.Men whose wives conceived spontaneously. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Male patients participating in fertility treatments.
Key inclusion criteria (1 listed)
- Participation in fertility treatments.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and personal interviews.Questionnaire and personal interviews. | Other | Fertility treatments, Spontaneous pregnancy |
Primary outcome
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.
2 secondary outcomes
Sexual intercourse rate.
Time frame: From recruitment up to 3 years.
Use of phospho-di-esterase 5 inhibitors
Time frame: From recruitment up to 3 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy Lauterbach, MD principal investigator
Rambam healthcare campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in International index of erectile function score (time frame: From recruitment up to 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.