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RA-2 13-cis Retinoic Acid (Isotretinoin) (RA-2)

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ClinicalTrials.gov Identifier: NCT02061384
Recruitment Status : Active, not recruiting
First Posted : February 12, 2014
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
John Amory, University of Washington

Tracking Information
First Submitted Date  ICMJE February 10, 2014
First Posted Date  ICMJE February 12, 2014
Last Update Posted Date May 4, 2018
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
Total motile sperm [ Time Frame: Up to 20-weeks ]
Total motile sperm count in men treated with 13-cis retinoic acid
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2014)
Effect of 13-cis retinoic acid administration on total motile sperm count [ Time Frame: 20-weeks ]
To determine the effect of 13-cis retinoic acid administration on total motile sperm count in men with oligoasthenoteratozoospermia
Change History Complete list of historical versions of study NCT02061384 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2016)
  • 13-cis retinoic acid serum level [ Time Frame: 20-weeks ]
    Concentration level of 13-cis retinoic acid in the serum of treated men
  • Number of Participants with Serious and Non-Serious Adverse effects associated with treatment with 13-cis retinoic acid [ Time Frame: 20-weeks ]
    Number of adverse effects per subject associated with treatment with 13-cis retinoic acid
  • 13-cis retinoic acid Seminal Plasma Concentration [ Time Frame: Up to 20-weeks ]
    13-cis retinoic acid concentration in semen of treated men
  • To determine if the additions of calcitriol with 13-cis retinoic acid can improve sperm motility [ Time Frame: 20 weeks ]
    improved sperm motility
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2014)
  • Concentration of 13-cis retinoic acid in the serum and seminal plasma [ Time Frame: 20-weeks ]
    To determine the concentration of 13-cis retinoic acid in the serum and seminal plasma of treated men
  • Side effects associated with treatment with 13-cis retinoic acid [ Time Frame: 20-weeks ]
    To determine the side effects associated with treatment with 13-cis retinoic acid
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RA-2 13-cis Retinoic Acid (Isotretinoin)
Official Title  ICMJE A Pilot Trial of 13-cis Retinoic Acid (Isotretinoin) for the Treatment of Men With Oligoasthenoteratozoospermia
Brief Summary Men with infertility and normal hormone levels have few options for fertility treatment. Previous research work has suggested that men with infertility may have low levels of the active form of Vitamin A, called retinoic acid, in their testes. We think that giving men with low sperm counts retinoic acid may increase their sperm counts and improve their chances of fathering a pregnancy. We want to see if retinoic acid administration over twenty weeks can increase sperm production and help infertile men become fathers without the need for In vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). We also want to see if adding calcitriol with retinoic acid will improve sperm motility in a sub-set of subjects.
Detailed Description This is a 20 week, unblinded, two-arm pilot study to determine the impact of therapy with 13-cis retinoic acid and calcitriol on sperm indices in infertile men. Twenty infertile men, ages 21-60 with abnormal sperm analyses will be enrolled for 20-week and given 20 mg 13-cis retinoic acid, twice daily. Subjects#11-#20 will also be administered calcitriol to see if adding calcitriol with Accutane will improve sperm motility. All subjects will be closely followed for side effects related to treatment. The impact of treatment on indices of spermatogenesis will be determined by monthly seminal fluid analyses.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Male Infertility
  • Klinefelter's Syndrome
  • Y-chromosome Microdeletions
Intervention  ICMJE
  • Drug: 13-cis retinoic acid
    Accutane is used for the treatment of severe acne
    Other Names:
    • Accutane
    • Isotretinoin
  • Drug: Calcitriol
    Calcitriol is a form of vitamin D given twice daily (BID)
    Other Name: 1,25-dihydroxyvitamin D3
Study Arms  ICMJE
  • Experimental: 13-cis retinoic acid
    20mg 13-cis retinoic acid twice daily (BID) with meals for 20 weeks
    Intervention: Drug: 13-cis retinoic acid
  • Experimental: Calcitriol 0.25 mcg
    oral calcitriol 025 mcg BID subjects 11-20 for 20 weeks
    Intervention: Drug: Calcitriol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 10, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects will be infertile men (no pregnancy with partner with normal cycles and normal hysterosalpingogram despite >1 year of unprotected intercourse).
  • Abnormal sperm analyses with a total, motile sperm count of less than 10 million sperm as assessed by semen analysis on two occasions separated by one week.
  • In the opinion of the investigator, is able to comply with the protocol, understand and sign an informed consent and HIPAA (Health Insurance Portability and Accountability Act ) form.

Exclusion Criteria:

  • Men participating in another clinical trial
  • Men not living in the catchment area of the clinic
  • Clinically significant abnormal findings at screening
  • Known genetic infertility (e.g. Klinefelter syndrome or Y-chromosome microdeletions),
  • Hypogonadotropic hypogonadism (that might respond to gonadotropin injections),
  • The use of anabolic steroids, illicit drugs, or the consumption of more than 4 alcoholic beverages daily
  • Severe mental health problems requiring medications
  • Current therapy with retinoic acid (e.g. Accutane) or vitamin A.
  • Score of greater than 15 on the Patient health questionnaire (PHQ9).
  • Abnormal serum chemistry values according to local laboratory normal values which indicate liver or kidney dysfunction. Other abnormal lab values may also be exclusionary, at the discretion of the investigator
  • Men with a personal history of serious psychiatric disorders
  • Men currently receiving tetracycline containing medications
  • Men currently receiving phenytoin
  • Men with a history of inflammatory bowel disease
  • Men with a history of bone disease
  • Men who have used isotretinoin within eight weeks of the start of dosing
  • Men with elevated serum triglycerides
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02061384
Other Study ID Numbers  ICMJE STUDY00000564
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Amory, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John K Amory, MD, MPH University of Washington
PRS Account University of Washington
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP