Comparative Evaluation of the Efficacy of Letrozole, L-Carnitine, and Their Combination on Sperm Quality, Oxidative Stress, and ART Outcomes in Men With Idiopathic Oligoasthenoteratozoospermia.

NCT07669402 on ClinicalTrials.gov Phase 2/3 Tehran University of Medical Sciences (academic or other) Started 2023-12-01 Completed

Riskier than 8% of active trials

Model scores of the 29,894 trials active now.

Model score 7% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (60 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2026-03-31, after 2023-12-01 start.

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2026-03-31. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: stressqualityoutcomesmonthsidiopathic
Phrases that lowered it: the efficacytestosteroneclinical trialcombinationart
Sponsor's past termination rate: 1.7% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Minimum age: 20 (lowers risk) · Who can join
Blinding: quadruple (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: 9.9% (lowers risk) · Drug's FDA history
Sponsor type: academic or other (raises risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Number of arms: 3 (lowers risk) · Design
Sponsor's past trials: 120 (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 8 (raises risk) · Sponsor's track record
Drug's FAERS reports marked serious: 79.6% (lowers risk) · Drug's FDA history
Disease area, neurology: No (lowers risk) · Disease area

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 2/3 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: quadruple (typical: none)
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 8 (typical: 1)

Who can join

Minimum age: 20 (typical: 18)
Maximum age: 45 (typical: 71)
Sex: male (typical: all)
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 120 (typical: 32)
Sponsor's past termination rate: 1.7% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 8 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 2 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 52021 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 5994 (typical: 412.5)
Drug's FAERS reports marked serious: 79.6% (typical: 85.6%)
Drug's FAERS reports with a death: 9.9% (typical: 15.9%)

Disease area and drugs

Disease areas: urogenital
Drugs matched to FDA substances: carnitine, letrozole

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

Effect of Letrozole on Seminal Parameters in Men With Non Obstructive Azoospermia and Severe Oligozoospermia. NCT02900105 · started 2015 · scored riskier than 9% of active trials completed
Comparison of Acetyl- L- Carnitine& Folic Acid Versus Coenzyme Q10& Folic Acid on Semen& Hormonal Parameters& Semen Oxidative Status in Patients of Primary Infertility. A Double Blind Randomized Clinical Trial NCT05616000 · started 2022 · scored riskier than 4% of active trials completed
Clomiphene Citrate in Infertile Men With Idiopathic Oligoasthenozoospermia NCT06564961 · started 2022 · scored riskier than 9% of active trials completed
Effect of ALA Combined With Letrozole on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females NCT06418347 · started 2024 · scored riskier than 21% of active trials completed
Extended Letrozole Regimen Versus Clomiphene Citrate for Superovulation in Patients With Unexplained Infertility Undergoing Intrauterine Insemination NCT01232075 · started 2008 · scored riskier than 9% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.