Trial · NCT01297465
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Number of Oocytes Retrieved | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 11 days}]) | Modified intention-to-treat (Mod-ITT) population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment. | oocytes | MEAN |
| SECONDARY | Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH) | Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days]) | Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. | IU | MEAN |
| SECONDARY | Total Number of Stimulation Treatment Days | Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days]) | Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. | days | MEAN |
| SECONDARY | Implantation Rate | Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) | Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment. | percent sacs per embryo | MEAN |
| SECONDARY | Number of Fetal Sacs With Activity | Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}]) | Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | fetal sacs | MEAN |
| SECONDARY | Number of Fetal Hearts With Activity | Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}]) | Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | fetal hearts | MEAN |
| SECONDARY | Clinical Pregnancy Rate | Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) | Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and had completed the primary efficacy assessment. N signifies those participants who had their ET in study treatment cycle. n signifies those participants who were evaluated for this measure in specified categories. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Cancelled Cycles Due to Excessive or Insufficient Ovarian Response to Treatment | S1 until Day 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) | Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. | participants | NUMBER |
| SECONDARY | Biochemical Pregnancies Rate | Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) | Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment. . N (number of participants analyzed) signifies those participants who had their embryo transfer in study treatment cycle. | participants | NUMBER |
| SECONDARY | Number of Participants With Multiple Pregnancies | Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) | Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment. N (number of participants analyzed) signifies those participants who had their embryo transfer in study treatment cycle. | participants | NUMBER |
| SECONDARY | Number of Participants With Early and Late Ovarian Hyper Stimulation Syndrome (OHSS) | Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) | Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. | participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events | Day 1 up to days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) | Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. | participants | NUMBER |
| SECONDARY | Systolic and Diastolic Arterial Blood Pressure Assessments | Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) | Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. .N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | millimeter of mercury ( mm Hg) | MEAN |
| SECONDARY | Heart Rate Assessments | Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) | Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. .N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | beats per minute (bpm) | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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