Trial · NCT03323801
RA-4: 13-cis Retinoic Acid for Treatment of Men With Azoospermia
NCT03323801, Phase 2, Completed, University of Washington; results first posted 2021-10-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RA-4: 13-cis Retinoic Acid for Treatment of Men With Azoospermia. Trials, record NCT03323801. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03323801
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RA-4: 13-cis Retinoic Acid for Treatment of Men With Azoospermia
- NCT number
- NCT03323801
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Male Infertility, Azoospermia
- Interventions
- 13-cis retinoic acid
- First posted
- 2017-10-27
- Last updated
- 2021-10-26
- Results first posted
- 2021-10-26
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Motile Sperm | up to 32 weeks | Number of participants with undetectable or detectable sperm in their ejaculates. |
| Primary | Total Sperm and Percentage of These Sperm That Were Motile | 32 weeks | Number of total sperm in ejaculate and percentage of these sperm that were motile |
| Secondary | Serious and Non-Serious Adverse Effects | 32 weeks | Number of participants with Serious and Non-Serious Adverse effects associated with treatment with 13-cis retinoic acid |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Motile Sperm | up to 32 weeks | Men had idiopathic azoospermia, without evidence of obstruction or know genetic causes of azoospermia, although one man had known AZFc deletion | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Total Sperm and Percentage of These Sperm That Were Motile | 32 weeks | Only man who developed sperm in ejaculate on treatment | Percent of sperm that were motile | NUMBER |
| SECONDARY | Serious and Non-Serious Adverse Effects | 32 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Motile Sperm | Accutane-13-cis Retinoic Acid | undetectable | 8 | Participants | |
| Total Motile Sperm | Accutane-13-cis Retinoic Acid | detectable motile sperm | 1 | Participants | |
| Total Sperm and Percentage of These Sperm That Were Motile | 13-cis Retinoic Acid | 20 | Percent of sperm that were motile | ||
| Serious and Non-Serious Adverse Effects | Accutane-13-cis Retinoic Acid | 1 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 13-cis Retinoic Acid | 10 | |
| Overall Study | COMPLETED | 13-cis Retinoic Acid | 10 | |
| Overall Study | NOT COMPLETED | 13-cis Retinoic Acid | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | cramps | Musculoskeletal and connective tissue disorders | Accutane-13-cis Retinoic Acid | 1 | 10 | 1 |
| serious | nephrotic syndrome | Gastrointestinal disorders | Accutane-13-cis Retinoic Acid | 1 | 10 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Accutane-13-cis Retinoic Acid | 0 | 10 |
| Total, other adverse events | Accutane-13-cis Retinoic Acid | 1 | 10 |
| Total, serious adverse events | Accutane-13-cis Retinoic Acid | 1 | 10 |
Source ClinicalTrials.gov
Papers16
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| K24HD082231 | Retinoic Acid in Male Infertility | AMORY, JOHN K. | UNIVERSITY OF WASHINGTON | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2015 to 2019 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03323801
GET https://conductscience.org/api/trials/v1/NCT03323801/registered