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Male Infertility | RA-2 13-cis Retinoic Acid (Isotretinoin)

Male Infertility research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Male Infertility

Klinefelter's Syndrome

Y-chromosome Microdeletions

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:13-cis retinoic acidAccutane is used for the treatment of severe acne

Drug:CalcitriolCalcitriol is a form of vitamin D given twice daily (BID)

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

13-cis retinoic acid20mg 13-cis retinoic acid twice daily (BID) with meals for 20 weeks

Calcitriol 0.25 mcgoral calcitriol 025 mcg BID subjects 11-20 for 20 weeks

Study Status

Active, not recruiting

Start Date: August 2014

Completed Date: December 2018

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Total motile sperm

Secondary Outcome: 13-cis retinoic acid serum level

Study sponsors, principal investigator, and references

Principal Investigator: John K Amory, MD, MPH

Lead Sponsor: University of Washington

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02061384

Jequier AM, Holmes SC. Primary testicular disease presenting as azoospermia or oligozoospermia in an infertility clinic. Br J Urol. 1993 Jun;71(6):731-5.

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