Status:
ACTIVE_NOT_RECRUITING
The Impact of Prednisone on Semen Parameters and Pregnancy Rates Post Vasectomy Reversal
Lead Sponsor:
Charitable Union for the Research and Education of Peyronie's Disease
Conditions:
Vasectomy Reversal
Eligibility:
MALE
18-65 years
Phase:
PHASE4
Brief Summary
1. Determine impact of prednisone on semen parameters post vasectomy reversal (evaluated both using prednisone as a combined cohort as well as via 3 separate protocols). 2. Determine impact of prednis...
Detailed Description
1\. Introduction This document is a protocol for a randomized, controlled clinical trial. This study will be carried out in accordance with the procedures described in this protocol, applicable Unite...
Eligibility Criteria
Inclusion
- Men undergoing a first-time vasectomy reversal at the Male Fertility and Peyronie's Clinic
- 18-65 years of age
- Current sexual partner with desire to achieve pregnancy immediately
- Intent of reversal to restore fertility
- Partner \<36 years of age
- Partner with no known fertility issues
- Prior history of paternity
Exclusion
- Current corticosteroid use
- Prior vasectomy reversal
- Prior chemotherapy
- Testosterone use within 1 year of the vasectomy reversal
- Solitary testicle
- History of diabetes mellitus
- History of systemic fungal infection
- Hypertension
- Any degree of diagnosed renal insufficiency
- Partner on birth control within past 3 months
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04788823
Start Date
February 24 2021
End Date
February 1 2026
Last Update
February 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cure PD
Orem, Utah, United States, 84057