Comparison · NCT01071200-sae
FSH + rhLH vs Follicle-stimulating Hormone (FSH): 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. FSH + rhLH vs Follicle-stimulating Hormone (FSH): serious adverse events. Trial comparisons, record NCT01071200-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01071200-sae
On this page
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 | 0.0149 | 0.00264 | 0.0798 | wilson | |
| Risk in group 2 | 0.0303 | 0.00835 | 0.104 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0154 | -0.09 | 0.0531 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.493 | 0.0458 | 5.3 | log | |
| Odds ratio, group 1 over group 2 | 0.485 | 0.0429 | 5.48 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on FSH + rhLH than on Follicle-stimulating Hormone (FSH) | 65 | 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 | FSH + rhLH | Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH). | 1 | 67 | EG000 |
| Group 2 | Follicle-stimulating Hormone (FSH) | FSH injection administered according to investigator's discretion till r-hCG administration day. | 2 | 66 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
AEs are collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the post-treatment safety, on day 12-18 post-hCG administration. AEs are classified as pre-treatment, treatment-emergent and post-treatment.
Source ClinicalTrials.gov
Trial
- Title
Study to Evaluate if the Addition of r-hLH (Luveris®) to FSH From Day 8 of Ovarian Stimulation is Able to Decrease Total FSH Dose and to Improve Cycle Outcome in Infertile Women Undergoing ART, Who Required High FSH Dose in a Previous Cycle
- NCT number
- NCT01071200
- Phases
- PHASE3
- Conditions
- Reproductive Techniques, Assisted
- Interventions
- Recombinant human Follicle Stimulating Hormone (r-hFSH) and Recombinant human Luteinizing Hormone (r-hLH), r-hFSH
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Results first posted
- 2012-08-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01071200?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01071200-sae