Comparison · NCT05263388-sae
REKOVELLE (Follitropin Delta) vs GONAL-F (Follitropin Alfa): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. REKOVELLE (Follitropin Delta) vs GONAL-F (Follitropin Alfa): serious adverse events. Trial comparisons, record NCT05263388-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05263388-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0.00000000000000000173 | 0.0188 | wilson | |
| Risk in group 2 | 0.02 | 0.0055 | 0.07 | wilson | |
| Risk difference, group 1 minus group 2 | -0.02 | -0.07 | 0.00378 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on REKOVELLE (Follitropin Delta) than on GONAL-F (Follitropin Alfa) | 50 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | REKOVELLE (Follitropin Delta) | REKOVELLE (Follitropin Delta): REKOVELLE administered as single daily subcutaneous injections in the abdomen. The starting dose of REKOVELLE was 15 μg fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the gonadotropin-releasing hormone (GnRH) antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily REKOVELLE dose could be increased or decreased by 5 μg based on the subject's response. The minimum REKOVELLE dose was 5 μg and the maximum REKOVELLE was 20 μg. Subjects could be treated for a maximum of 20 days. | 0 | 200 | EG000 |
| Group 2 | GONAL-F (Follitropin Alfa) | GONAL-F (Follitropin Alfa): GONAL-F administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 225 IU fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the GnRH antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily GONAL-F dose could be adjusted by 75 IU based on the subject's response. The minimum GONAL-F dose was 75 IU and the maximum GONAL-F dose was 300 IU. Subjects could be treated for a maximum of 20 days. | 2 | 100 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 4 months
Source ClinicalTrials.gov
Trial
- Title
- A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation
- NCT number
- NCT05263388
- Phases
- PHASE3
- Conditions
- Infertility
- Interventions
- REKOVELLE (Follitropin Delta), GONAL-F (Follitropin Alfa)
- Lead sponsor
- Ferring Pharmaceuticals
- Results first posted
- 2025-04-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05263388?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT05263388-sae