Comparison · NCT01079949-sae
r-hFSH + r-hLH vs r-hFSH: 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. r-hFSH + r-hLH vs r-hFSH: serious adverse events. Trial comparisons, record NCT01079949-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01079949-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 | 0.0444 | 0.0123 | 0.148 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0756 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0444 | -0.0377 | 0.148 | 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 harm, for one more participant with a serious adverse event on r-hFSH + r-hLH than on r-hFSH | 22.5 | 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 | r-hFSH + r-hLH | Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter \[mm\] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once. | 2 | 45 | EG000 |
| Group 2 | r-hFSH | Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once. | 0 | 47 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- S1 up to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])
Source ClinicalTrials.gov
Trial
- Title
- A Phase II Study to Assess the Efficacy and Safety of Luveris® (Lutropin Alfa) in Mid Follicular Phase for Controlled Ovarian Stimulation (COS) in Advanced Reproductive Age
- NCT number
- NCT01079949
- Phases
- PHASE2
- Conditions
- Infertility, Ovulation Induction
- Interventions
- r-hLH + r-hFSH, r-hFSH, Recombinant Human Choriogonadotropin (r-hCG), GnRH antagonist
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Results first posted
- 2013-02-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01079949?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.
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