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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryTotal Motile Spermup to 32 weeksNumber of participants with undetectable or detectable sperm in their ejaculates.
PrimaryTotal Sperm and Percentage of These Sperm That Were Motile32 weeksNumber of total sperm in ejaculate and percentage of these sperm that were motile
SecondarySerious and Non-Serious Adverse Effects32 weeksNumber of participants with Serious and Non-Serious Adverse effects associated with treatment with 13-cis retinoic acid

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYTotal Motile Spermup to 32 weeksMen had idiopathic azoospermia, without evidence of obstruction or know genetic causes of azoospermia, although one man had known AZFc deletionParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYTotal Sperm and Percentage of These Sperm That Were Motile32 weeksOnly man who developed sperm in ejaculate on treatmentPercent of sperm that were motileNUMBER
SECONDARYSerious and Non-Serious Adverse Effects32 weeksParticipantsCOUNT_OF_PARTICIPANTS

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Total Motile SpermAccutane-13-cis Retinoic Acidundetectable8Participants
Total Motile SpermAccutane-13-cis Retinoic Aciddetectable motile sperm1Participants
Total Sperm and Percentage of These Sperm That Were Motile13-cis Retinoic Acid20Percent of sperm that were motile
Serious and Non-Serious Adverse EffectsAccutane-13-cis Retinoic Acid1Participants

Participant flow3

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTED13-cis Retinoic Acid10
Overall StudyCOMPLETED13-cis Retinoic Acid10
Overall StudyNOT COMPLETED13-cis Retinoic Acid0

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
othercrampsMusculoskeletal and connective tissue disordersAccutane-13-cis Retinoic Acid1101
seriousnephrotic syndromeGastrointestinal disordersAccutane-13-cis Retinoic Acid1101

Adverse event totals3

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityAccutane-13-cis Retinoic Acid010
Total, other adverse eventsAccutane-13-cis Retinoic Acid110
Total, serious adverse eventsAccutane-13-cis Retinoic Acid110

Papers16

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
1398387BACKGROUNDPubMed
3159708BACKGROUNDPubMed
3481225BACKGROUNDPubMed
8102079BACKGROUNDPubMed
8388780BACKGROUNDPubMed
8394014BACKGROUNDPubMed
9074589BACKGROUNDPubMed
10506831BACKGROUNDPubMed
10529278BACKGROUNDPubMed
16461896BACKGROUNDPubMed

1 to 10 of 16

See all 16 papers

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
K24HD082231Retinoic Acid in Male InfertilityAMORY, JOHN K.UNIVERSITY OF WASHINGTONEUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT2015 to 2019

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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