Comparison · NCT01112358-e3d103a7
r-FSH + r-hLH vs r-FSH: Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. r-FSH + r-hLH vs r-FSH: Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled. Trial comparisons, record NCT01112358-e3d103a7. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01112358-e3d103a7
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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 | 0.32 | 0.172 | 0.516 | wilson | |
| Risk in group 2 | 0.242 | 0.128 | 0.41 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0776 | -0.146 | 0.304 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.32 | 0.575 | 3.03 | log | |
| Odds ratio, group 1 over group 2 | 1.47 | 0.462 | 4.68 | log | |
| Number needed to treat, for one more participant with the outcome on r-FSH + r-hLH than on r-FSH | 12.9 | 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-FSH + r-hLH | Lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8). | 8 | 25 | OG000 |
| Group 2 | r-FSH | Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8). | 8 | 33 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled
- Description
- Time frame
- Randomization to Day 8
- Population
- ITT population
Source ClinicalTrials.gov
Trial
- Title
- Lutropin Alfa in Women at Risk of Poor Response
- NCT number
- NCT01112358
- Phases
- PHASE2
- Conditions
- Ovarian Stimulation
- Interventions
- r-FSH, r-hLH, Analogous GnRH antagonist, r-hCG, Progesterone
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Results first posted
- 2018-07-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01112358?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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