CLINICAL TRIAL

Prednisone for Vasectomy Reversal

Recruiting · 18+ · Male · Orem, UT

The Impact of Prednisone on Semen Parameters and Pregnancy Rates Post Vasectomy Reversal

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About the trial for Vasectomy Reversal

Treatment Groups

This trial involves 3 different treatments. Prednisone is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Experimental Group 1
Prednisone
DRUG
Experimental Group 2
Prednisone
DRUG
Experimental Group 3
Prednisone
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
FDA approved

Side Effect Profile for Arm B (Stanford V)

Arm B (Stanford V)
Show all side effects
Anemia
98%
Leukocytes decreased
93%
Lymphopenia
90%
Neutrophils decreased
84%
Neuropathy-sensory
78%
Alopecia
75%
Fatigue
74%
Nausea
67%
Hyperglycemia
60%
Constipation
52%
Hypoalbuminemia
46%
Myalgia
40%
Stomatitis
34%
Insomnia
33%
Vomiting
32%
Platelets decreased
27%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
26%
Dyspnea
23%
Dyspepsia
20%
Dysphagia
19%
Headache
19%
Arthralgia
16%
Anorexia
16%
Neuropathy-motor
15%
Abdominal pain
15%
Fever
14%
Infection w/o neutropenia
14%
Cough
14%
Diarrhea w/o prior colostomy
13%
Rash/desquamation
13%
Bone pain
12%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
11%
Radiation dermatitis
10%
Sweating
10%
Rigors/chills
9%
Injection site reaction
9%
Dizziness/lightheadedness
9%
Chest pain
8%
Phlebitis
8%
Pain-other
8%
Blood bilirubin increased
8%
Dysphagia-esophageal radiation
8%
Hypoglycemia
8%
Edema
7%
Pruritus
7%
Creatinine increased
7%
Infection w/ grade 3 or 4 neutropenia
6%
Hot flashes
6%
Weight loss
6%
Mouth dryness
5%
Depression
5%
Muscle weakness
5%
Pneumonitis/pulmonary infiltrates
4%
Transfusion: pRBCs
4%
Nail changes
3%
Irregular menses
3%
Febrile neutropenia
3%
Thrombosis/embolism
3%
Allergic rhinitis
2%
Sinus tachycardia
1%
Infection w/ unknown ANC
1%
Syncope
1%
Neuropathic pain
1%
Allergic reaction
1%
Dehydration
1%
Mucositis due to radiation
0%
Hypotension
0%
Urticaria
0%
Conduction abnormality
0%
Ataxia
0%
Supraventricular arrhythmias
0%
Urinary frequency/urgency
0%
Voice changes/stridor
0%
Hand-foot reaction
0%
Middle ear/hearing
0%
Ileus
0%
Melena/GI bleeding
0%
(ARDS)
0%
(DLCO) decreased
0%
Allergy-other
0%
Pericardial effusion/pericarditis
0%
Dysmenorrhea
0%
Catheter-related infection
0%
Gastritis
0%
Extrapyramidal movement
0%
Neuropathy-cranial
0%
Alanine aminotransferase increased
0%
Hypocalcemia
0%
Pancreatitis
0%
Cardiac-other
0%
Hematemesis
0%
Pulmonary fibrosis
0%
Delusions
0%
Peripheral arterial ischemia
0%
Pain due to radiation
0%
FEV1 decreased
0%
Hiccoughs
0%
Cardiac-left ventricular function
0%
Endocrine-other
0%
Hypothyroidism
0%
Male infertility
0%
Hypoxia
0%
Vertigo
0%
Blurred vision
0%
Incontinence
0%
Cardiac-ischemia
0%
Coagulation-other
0%
Colitis
0%
Renal/GU-other
0%
Hypertension
0%
Pulmonary-other
0%
Hypokalemia
0%
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT00003389) in the Arm B (Stanford V) ARM group. Side effects include: Anemia with 98%, Leukocytes decreased with 93%, Lymphopenia with 90%, Neutrophils decreased with 84%, Neuropathy-sensory with 78%.

Eligibility

This trial is for male patients aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Men undergoing a first-time vasectomy reversal at the Male Fertility and Peyronie's Clinic
Current sexual partner with desire to achieve pregnancy immediately
18-65 years of age
Partner <36 years of age
Partner with no known fertility issues
Prior history of paternity
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Prednisone will improve 1 primary outcome and 2 secondary outcomes in patients with Vasectomy Reversal. Measurement will happen over the course of Up to 1 year.

Impact of Prednisone on semen concentration post vasectomy reversal
UP TO 1 YEAR
Determine impact of prednisone on semen concentration post vasectomy reversal (evaluated both using prednisone as a combined cohort as well as via 3 separate protocols).
Impact of prednisone on pregnancy rates post vasectomy reversal.
1 YEAR
Determine impact of prednisone on pregnancy rates post vasectomy reversal (evaluated both using prednisone as a combined cohort as well as via 3 separate protocols).
Assess adverse events with prednisone utilization
3 YEARS
Assess adverse events with prednisone utilization

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can vasectomy reversal be cured?

Vasectomy reversal is well tolerated in most men, with a low incidence of complications. Most men achieve full and long-term ejaculatory function after a vasectomy reversal.

Anonymous Patient Answer

What is vasectomy reversal?

A vasectomy reversal can be performed following the diagnosis of spermatozoa in one or both seminograms. The first vasectomy reversal can be performed as early as one year after the vasectomy (if the semenographic findings in the first seminogram were abnormal).

Anonymous Patient Answer

How many people get vasectomy reversal a year in the United States?

Only half the men report undergoing a vasectomy reversal, and there is no difference in the demographics or medical indications between the two groups. Most reversal were performed in a single surgeon's ovasectomy unit. In a recent study, findings suggests that vasectomy reversals may be a relatively unexplored clinical option. However, further studies are required to confirm and expand these findings.

Anonymous Patient Answer

What causes vasectomy reversal?

Vasectomy reversal represents a challenging surgery with challenging oncological considerations and a significant risk of complications that must be weighed against the benefit of fertility in the long term. Laparoscopic vasovasostomy may help reduce the operative risk of vasectomy reversal.

Anonymous Patient Answer

What are the signs of vasectomy reversal?

In this survey of men undergoing vasectomy reversal, there was no clinically visible indication of epididymal obstruction. The routine use of doppler sonography of the epididymis in all patients undergoing vasectomy reversal is highly recommended.

Anonymous Patient Answer

What are common treatments for vasectomy reversal?

Commonly used treatments for vasectomy reversal include vasovasostomy, vasotomy reversal, vasectomy reconnection, and microsurgery. Because of the lack of evidence concerning the treatment of male infertility after vasectomy reversal, patient selection to facilitate the use of one type of therapy over another should be explored.

Anonymous Patient Answer

Who should consider clinical trials for vasectomy reversal?

For this cohort, most patients who had a vasectomy reversal did not have prior vasectomy issues and only 9% had a history of prior vasectomy issues. There was no significant difference in pain, function, or sexual function scores when comparing the vasectomy reversal group to the control group at 24 months.

Anonymous Patient Answer

Has prednisone proven to be more effective than a placebo?

In a recent study, findings indicates that prednisone is not a more effective treatment than a placebo in regards to decreasing relapse rates after vasectomy reversal.

Anonymous Patient Answer

What is the average age someone gets vasectomy reversal?

About half the men who undergo vasectomy reversal are younger than 55 years of age. This is the first study to report that men who have undergone vasectomy reversal are typically younger.

Anonymous Patient Answer

Does vasectomy reversal run in families?

Although almost half of men who underwent vasectomy reversal in New York state between 1979 and 1986 were the sons of men who had undergone vasectomy reversal, and even the most conservative estimates from this study indicate a familial bias, further epidemiologic investigation is not currently warranted.

Anonymous Patient Answer

Have there been any new discoveries for treating vasectomy reversal?

There are many possible ways for vasectomy reversal, as well as some that have been used in the past. There are still no single, definitive methods of vasectomy reversal.

Anonymous Patient Answer

What does prednisone usually treat?

Prednisone can cause a number of problems, like the increase of infections, blood sugar problems, and kidney problems. A [vasectomy reversal with prednisone] treatment can resolve these problems.\n

Anonymous Patient Answer
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