Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment
Model scores of the 29,894 trials active now.
Model score 5% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 9% of the time (181 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2013-03-31, after 2010-06-30 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2013-03-31. 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
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: stagechronicseverediseasealfa
Phrases that lowered it: dayendocrineand safetyabnormalproducts -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Minimum age: 20 (lowers risk) · Who can join
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
-
Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Disease area, neurology: No (lowers risk) · Disease area
-
Blinding: single (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 77.8% (lowers risk) · Drug's FDA history
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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- single (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 18)
- Maximum age
- 38 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 9 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- 77.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- follitropin alfa
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
- Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF NCT01687712 · started 2013 · scored riskier than 12% of active trials completed
- A Randomized, Multicentre, Open Label, Evaluator Blinded Study to Evaluate Safety and Efficacy of Folitime® of Gemabiotech S.A., Versus Gonal-f ® of Merck Serono, in Patients With Infertility Undergoing ART NCT02454556 · started 2015 · scored riskier than 10% of active trials completed
- Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART) NCT02047227 · started 2014 · scored riskier than 28% of active trials completed
- Randomized Controlled Study of Comparing Follitrope Versus Gonal-f in Chinese Infertility Women. NCT03506243 · started 2015 · scored riskier than 8% of active trials completed
- Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment NCT03088137 · started 2017 · scored riskier than 5% 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.