Trial record 16 of 18 for:    "klinefelter syndrome"

RA-2 13-cis Retinoic Acid (Isotretinoin)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by University of Washington
Sponsor:
Information provided by (Responsible Party):
John Amory, University of Washington
ClinicalTrials.gov Identifier:
NCT02061384
First received: February 10, 2014
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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 intracytoplasmic sperm injection (IVF) and/or ICSI.


Condition Intervention Phase
Male Infertility
Klinefelter's Syndrome
Y-chromosome Microdeletions
Drug: 13-cis retinoic acid
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Trial of 13-cis Retinoic Acid (Isotretinoin) for the Treatment of Men With Oligoasthenoteratozoospermia

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Total motile sperm [ Time Frame: Up to 20-weeks ] [ Designated as safety issue: No ]
    Total motile sperm count in men treated with 13-cis retinoic acid


Secondary Outcome Measures:
  • 13-cis retinoic acid serum level [ Time Frame: Up to 20-weeks ] [ Designated as safety issue: No ]
    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: Up to 20-weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    13-cis retinoic acid concentration in semen of treated men


Estimated Enrollment: 20
Study Start Date: July 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 13-cis retinoic acid
20mg 13-cis retinoic acid twice daily with meals for 20 weeks
Drug: 13-cis retinoic acid
Other Names:
  • Accutane
  • Isotretinoin

Detailed Description:

This is a 20 week, unblinded, single-arm pilot study to determine the impact of therapy with 13-cis retinoic acid 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. 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.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 PHQ9 questionnaire.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02061384

Contacts
Contact: Iris Nielsen 206-221-5473 nielseni@uw.edu
Contact: Kathy Winter 206-616-0484 klwinter@uw.edu

Locations
United States, Washington
University of Washington Medical Center Not yet recruiting
Seattle, Washington, United States, 98195
Contact: Iris Nielsen    206-221-5473    inielsen@uw.edu   
Principal Investigator: John K Amory, MD, MPH         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: John K Amory, MD, MPH University of Washington
  More Information

Publications:

Responsible Party: John Amory, Professor & Section Head, General Internal Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT02061384     History of Changes
Other Study ID Numbers: 46478-A
Study First Received: February 10, 2014
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
Infertility

Additional relevant MeSH terms:
Klinefelter Syndrome
Infertility
Infertility, Male
Chromosome Deletion
Sex Chromosome Aberrations
Sex Chromosome Disorders of Sex Development
Genital Diseases, Male
Genital Diseases, Female
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Hypogonadism
Monosomy
Aneuploidy
Chromosome Aberrations
Pathologic Processes
Isotretinoin
Tretinoin
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Keratolytic Agents

ClinicalTrials.gov processed this record on August 28, 2014