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NCT02061384 · ClinicalTrials.gov registry record · Phase 2
RA-2 13-cis Retinoic Acid (Isotretinoin)
A Phase 2 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT02061384: Completed Phase 2 study, sponsored by University of Washington.
NCT02061384 is a Phase 2 study that has completed, run by University of Washington. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02061384, a Phase 2 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
Millions of sperm per ejaculate in men treated with 13-cis retinoic acid
Interventions
- DRUG Calcitriol
- DRUG 13-cis retinoic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-08 |
| Est. Completion | 2018-12 |
| Phase | Phase 2 |
What the finished NCT02061384 record still lists
NCT02061384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Calcitriol is the first listed.
NCT02061384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02061384 about?
NCT02061384 is a clinical study titled "RA-2 13-cis Retinoic Acid (Isotretinoin)". 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 ...
What is the current status of trial NCT02061384?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2014-08. Estimated completion is 2018-12.
What interventions are being tested in trial NCT02061384?
The interventions under investigation include: Calcitriol (DRUG), 13-cis retinoic acid (DRUG).
Who is sponsoring clinical trial NCT02061384?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02061384's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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