VasectomyEarly Phase 1NCT07245628
A Trial of Self-Adjusted Nitrous Versus Placebo During Office Vasectomy
A Early Phase 1 study testing Nitrous Oxide and Oxygen in people with Vasectomy, run by Alexandra J. Berger Eberhardt, MD at 1 site in United States.
Trial summary
The goal of this clinical trial is to see if nitrous oxide is safe and effective to use during during vasectomies performed in a clinic/in-office setting. This trial will compare self-administered nitrous oxide versus a placebo (oxygen) during office vasectomy. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Vasectomy
- What is being tested?
- Nitrous Oxide and Oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2025to 1 May 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 85 at the time of screening
- Desiring vasectomy for family planning purposes
- Able to understand and complete patient questionnaires
- Willing and able to provide written consent to participate in the study
Who cannot join
- Patients with unilateral absence of the vas deferens
- Patients who are deemed by study surgeons to have anatomy no amendable for office procedure
- Patients who decline office vasectomy and request monitored anesthesia care
- Patients taking benzodiazepine or narcotic medication daily or within 24 hours of the procedure
- Patients with contraindications to nitrous oxide including:
- Inner ear, bariatric, or eye surgery within the past 2 weeks
Show all 10Show fewer
- Current emphysematous blebs
- Severe B-12 deficiency
- History of bleomycin chemotherapy within the last year
- Class III or higher heart failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Alexandra J Berger Eberhardt, MD, 617-983-4521, ajberger@bwh.harvard.edu
About this study
Official title: A Single-Blind Randomized Placebo Controlled Trial of Self-Adjusted Nitrous Oxide During Office Vasectomy
The goal of this clinical trial is to see if nitrous oxide is safe and effective to use during during vasectomies performed in a clinic/in-office setting.
This trial will compare self-administered nitrous oxide versus a placebo (oxygen) during office vasectomy.
Read more
The main questions it aims to answer are:
- Whether self-administered low dose (20-45%) nitrous oxide (SANO) reduces intraoperative anxiety and catastrophizing during office vasectomy.
- To examine whether SANO reduces intraoperative pain or alters procedure duration, the rate of adverse events, or urologists' perception of ease and patient tolerance of the procedure.
Participants will be asked to complete multiple surveys pre-procedure, intra-procedure, and post-procedure.
- Conditions
- Vasectomy
- Being tested
- Nitrous Oxide, Oxygen
- Keywords
- Vasectomy, Nitrous Oxide, Men's Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous OxideDrug
Self-Administered Nitrous Oxide
OxygenDrug
Self-Administered Oxygen
| Study group | Role | What they receive |
|---|---|---|
| Nitrous Oxide | Experimental | Self-Administered Nitrous Oxide Receives: Drug: Nitrous Oxide |
| Placebo (Oxygen) | Placebo comparator | Self-Administered Placebo (Oxygen) Receives: Drug: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Difference in VAS-A During Vasectomy Procedure and S-PCS Immediately After Vasectomy Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide
Measuring the mean difference in Visual Analog Scale for Anxiety (VAS-A) during the vasectomy procedure and the Situational Pain Catastrophizing Scale (S-PCS) immediately after the vasectomy procedure, comparing those receiving and not receiving self-administered low dose nitrous oxide.
Intra-Procedure (Immediately After Injection of Local Anesthesia) Visual Analog Scale for Anxiety (VAS-A) (Zero is equivalent to no anxiety and 10 indicates the worst anxiety)
Intra-Procedure (In Between Left and Right Sides of Procedure) Visual Analog Scale for Anxiety (VAS-A) (Zero is equivalent to no anxiety and 10 indicates the worst anxiety)
Post-Procedure (10 Minutes After Procedure Completion, to Allow for Nitrous Oxide to be Metabolized)
- Situational Pain Catastrophizing Scale (S-PCS) (Zero is equivalent to not at all and 4 indicates all the time)
- Visual Analog Scale for Anxiety (VAS-A) (Zero is equivalent to no anxiety and 10 indicates the worst anxiety)
Measured: Intra-Procedure (Immediately After Injection of Local Anesthesia) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)
Secondary outcomes (6)
Mean Difference in Visual Analog Scale for Pain (VAS-P) Intra-Procedurally, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide
Intra-Procedure (Immediately After Injection of Local Anesthesia) Visual Analog Scale for Pain (VAS-P) (Zero is equivalent to no pain and 10 indicates the worst pain)
Intra-Procedure (In Between Left and Right Sides of Procedure) Visual Analog Scale for Pain (VAS-P) (Zero is equivalent to no pain and 10 indicates the worst pain)
Measured: Intra-Procedure (Immediately After Injection of Local Anesthesia) - Intra-Procedure (In Between Left and Right Sides of Procedure)
Mean Difference in VAS-P and STAI Pre- and Post-Procedurally, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide
Pre-Procedure (Day of Procedure, Immediately Prior)
- Visual Analog Scale for Pain (VAS-P) (Zero is equivalent to no pain and 10 indicates the worst pain)
- State Trait Anxiety Inventory (STAI) (1 is equivalent to not at all and 4 indicates very much)
Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)
- Visual Analog Scale for Pain (VAS-P) (Zero is equivalent to no pain and 10 indicates the worst pain)
- State Trait Anxiety Inventory (STAI) (1 is equivalent to not at all and 4 indicates very much)
Measured: Pre-Procedure (Day of Procedure, Immediately Prior) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)
Mean Difference in 30-Day Complications / Adverse Events, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide
Measured using the The Common Terminology Criteria for Adverse Events (CTCAE) grading scale (v5.0).
CTCAE v5.0 (1 is equivalent to mild and 5 indicates death related to AE)
Measured: Study Enrollment - 30 Days After Vasectomy
Urologist: Ease of Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide
Post-Procedure, Day of Vasectomy Ease of Procedure (1 is equivalent to the urologist determining the procedure went worse than expected and 3 indicates the urologist determines the procedure went better than expected)
Measured: Post-Procedure, Day of Vasectomy
Urologist: Patient Tolerance, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide
Patient Tolerance (1 is equivalent to the urologist determining the patient's tolerance for the procedure was worse than expected and 3 indicates the urologist determines the patient's tolerance for the procedure was better than expected)
Measured: Post-Procedure, Day of Vasectomy
Mean Difference in Duration of Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide
Measured: Intra-Procedure (Immediately After Injection of Local Anesthesia) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start20 Oct 2025
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasectomyStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandra J. Berger Eberhardt, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexandra J. Berger Eberhardt, MD, Brigham and Women's Hospital
- Investigators
- Alexandra J Berger Eberheardt, MD, Study chair, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245628
- Sponsor's protocol ID
- 2025P000258
- Status last verified
- Nov 2025
- First submitted
- 10 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind Randomized Placebo Controlled Trial of Self-Adjusted Nitrous Oxide During Office Vasectomy
- ClinicalTrials.gov ID
- NCT07245628
- Acronym / sponsor ID
- 2025P000258
- Conditions
- Vasectomy
- Keywords
- Vasectomy, Nitrous Oxide, Men's Health
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Alexandra J. Berger Eberhardt, MDUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 24 Nov 2025 (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.
The goal of this clinical trial is to see if nitrous oxide is safe and effective to use during during vasectomies performed in a clinic/in-office setting.
This trial will compare self-administered nitrous oxide versus a placebo (oxygen) during office vasectomy.
The main questions it aims to answer are:
- Whether self-administered low dose (20-45%) nitrous oxide (SANO) reduces intraoperative anxiety and catastrophizing during office vasectomy.
- To examine whether SANO reduces intraoperative pain or alters procedure duration, the rate of adverse events, or urologists' perception of ease and patient tolerance of the procedure.
Participants will be asked to complete multiple surveys pre-procedure, intra-procedure, and post-procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrous Oxide | Experimental | Drug: Nitrous OxideSelf-Administered Nitrous Oxide |
| Placebo (Oxygen) | Placebo comparator | Drug: OxygenSelf-Administered Placebo (Oxygen) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 - 85 at the time of screening
- Desiring vasectomy for family planning purposes
- Able to understand and complete patient questionnaires
- Willing and able to provide written consent to participate in the study
Key exclusion criteria (10 listed)
- Patients with unilateral absence of the vas deferens
- Patients who are deemed by study surgeons to have anatomy no amendable for office procedure
- Patients who decline office vasectomy and request monitored anesthesia care
- Patients taking benzodiazepine or narcotic medication daily or within 24 hours of the procedure
- Patients with contraindications to nitrous oxide including:
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 |
|---|---|---|
| Nitrous OxideSelf-Administered Nitrous Oxide | Drug | Nitrous Oxide |
| OxygenSelf-Administered Oxygen | Drug | Placebo (Oxygen) |
Primary outcome
Mean Difference in VAS-A During Vasectomy Procedure and S-PCS Immediately After Vasectomy Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide
Time frame: Intra-Procedure (Immediately After Injection of Local Anesthesia) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)
Measuring the mean difference in Visual Analog Scale for Anxiety (VAS-A) during the vasectomy procedure and the Situational Pain Catastrophizing Scale (S-PCS) immediately after the vasectomy procedure, comparing those receiving and not receiving self-administered low dose nitrous oxide. Intra-Procedure (Immediately After Injection of Local Anesthesia) Visual Analog Scale for Anxiety (VAS-A) (Zero is equivalent to no anxiety and 10 indicates the worst anxiety) Intra-Procedure (In Between Left and Right Sides of Procedure) Visual Analog Scale for Anxiety (VAS-A) (Zero is equivalent to no anxiety and 10 indicates the worst anxiety) Post-Procedure (10 Minutes After Procedure Completion, to Allow for Nitrous Oxide to be Metabolized) 1. Situational Pain Catastrophizing Scale (S-PCS) (Zero is equivalent to not at all and 4 indicates all the time) 2. Visual Analog Scale for Anxiety (VAS-A) (Zero is equivalent to no anxiety and 10 indicates the worst anxiety)
6 secondary outcomes
Mean Difference in Visual Analog Scale for Pain (VAS-P) Intra-Procedurally, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide
Time frame: Intra-Procedure (Immediately After Injection of Local Anesthesia) - Intra-Procedure (In Between Left and Right Sides of Procedure)
Mean Difference in VAS-P and STAI Pre- and Post-Procedurally, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide
Time frame: Pre-Procedure (Day of Procedure, Immediately Prior) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)
Mean Difference in 30-Day Complications / Adverse Events, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide
Time frame: Study Enrollment - 30 Days After Vasectomy
Urologist: Ease of Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide
Time frame: Post-Procedure, Day of Vasectomy
Urologist: Patient Tolerance, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide
Time frame: Post-Procedure, Day of Vasectomy
Mean Difference in Duration of Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide
Time frame: Intra-Procedure (Immediately After Injection of Local Anesthesia) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Yes
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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.
Alexandra J Berger Eberheardt, MD study chair
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nitrous Oxide and Oxygen in people with Vasectomy, run by Alexandra J. Berger Eberhardt, MD at 1 site in United States.
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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Difference in VAS-A During Vasectomy Procedure and S-PCS Immediately After Vasectomy Procedure, Comparing Participants Receiving and Not Receiving Self-Administered Low Dose Nitrous Oxide (time frame: Intra-Procedure (Immediately After Injection of Local Anesthesia) - Post-Procedure (10 Minutes After Procedure Completion, Allow for Nitrous Oxide to be Metabolized)). 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 24 Nov 2025.