Clinical Trial: RA-2 13-cis Retinoic Acid (Isotretinoin)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: University of Washington

Current Primary Outcome: Total motile sperm [ Time Frame: Up to 20-weeks ]

Total motile sperm count in men treated with 13-cis retinoic acid


Original Primary Outcome: 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


Current Secondary Outcome:

  • 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:

  • 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


Information By: University of Washington

Dates:
Date Received: February 10, 2014
Date Started: August 2014
Date Completion: December 2018
Last Updated: March 1, 2016
Last Verified: March 2016