RA-2 13-cis Retinoic Acid (Isotretinoin)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications, Other Indications, Other Indications, Women's Studies, Infertility |
| Therapuetic Areas: | Other, Reproductive |
| Healthy: | No |
| Age Range: | 21 - 60 |
| Updated: | 5/6/2018 |
| Start Date: | August 2014 |
| End Date: | December 2018 |
A Pilot Trial of 13-cis Retinoic Acid (Isotretinoin) for the Treatment of Men With Oligoasthenoteratozoospermia
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.
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.
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.
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.
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
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