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

NCT04788823 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: CUREPD 102
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.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).
3. 3.Assess adverse events with prednisone utilization

Conditions

Vasectomy Reversal

Outcome Measures

Primary Outcomes (3)

• Impact of Prednisone on semen concentration post vasectomy reversal

  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).

  3 years

• Impact of prednisone on pregnancy rates post vasectomy reversal.

  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).

  3 Years

• Assess adverse events with prednisone utilization

  Assess adverse events with prednisone utilization

  3 years

Secondary Outcomes (3)

• Impact of Prednisone on semen concentration post vasectomy reversal

  1 year

• Impact of prednisone on pregnancy rates post vasectomy reversal.

  1 year

• Impact of Prednisone on semen concentration post vasectomy reversal

  Up to 1 year

Study Arms (4)

Control

NO INTERVENTION

Group 1 will represent controls and will not receive prednisone in the 3-year post-op period.

Prednisone Monthly - Scheduled

EXPERIMENTAL

Group 2 will receive 3, one-month courses of prednisone (20 mg daily x 1 week, 10 mg daily x 1 week, 5 mg x 2 weeks). These will be given at the beginning of months 0, 2, and 4 and will be self-administered.

Drug: Prednisone

Prednisone Monthly - As Needed

EXPERIMENTAL

Group 3 will receive a maximum of 3, one-month courses of prednisone (20 mg daily x 1 week, 10 mg daily x 1 week, 5 mg x 2 weeks). These will be administered based on sequential semen analyses. If a semen analysis demonstrates a drop in concentration from a prior analysis or if it shows a 0 concentration, the course will be administered.

Drug: Prednisone

Prednisone Every Other Week

EXPERIMENTAL

Group 4 will receive alternating 1 week dosages of prednisone (1 week on, 1 week off - 5 mg daily only) for a total of 24 weeks

Drug: Prednisone

Interventions

Prednisone DRUG

Treatment groups will be administered different dosages of Prednisone post vasectomy reversal.

Prednisone Every Other Week; Prednisone Monthly - As Needed; Prednisone Monthly - Scheduled

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men undergoing a first-time vasectomy reversal at the Male Fertility and Peyronie's Clinic
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charitable Union for the Research and Education of Peyronie's Disease: lead

Study Sites (1)

Cure PD

Orem, Utah, 84057, United States

Location

Related Publications (1)

• Trost L, Helo S, Brearton K, Warner R, Ziegelmann M, Kohler T, Savage J. Impact of prednisone on vasectomy reversal outcomes (iPRED study): results from a randomized, controlled clinical trial. Fertil Steril. 2025 May;123(5):804-811. doi: 10.1016/j.fertnstert.2024.11.019. Epub 2024 Nov 20.

  PMID: 39577828 DERIVED

MeSH Terms

Interventions

Prednisone

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Benjamin Green

  The Male Fertility and Peyronie's Clinic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study cohort will be randomized to one of 4 arms: control or 3 different drug protocols.

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 9, 2021
• Study Start: February 24, 2021
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)