Phase 2
N=20
RA-2 13-cis Retinoic Acid (Isotretinoin)
Male Infertility · Klinefelter's Syndrome · Y-chromosome Microdeletions
Bottom Line
View on ClinicalTrials.gov: NCT02061384 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Millions of Sperm Per Ejaculate — 2.5; 3.8 Millions of sperm per ejaculate
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 13-cis retinoic acid (Drug); Calcitriol (Drug)
- Age
- Adult · 21+ yrs
- Sex
- Male
- Sponsor
- University of Washington
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Millions of Sperm Per Ejaculate |
2.5; 3.8 | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT02061384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.