Trial · NCT01079949
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Oocytes Retrieved | Ovum pick-up (OPU) day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) | Intention to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up. | oocytes | MEAN |
| PRIMARY | Number of Mature Oocytes Retrieved | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up. | mature oocytes | NUMBER |
| PRIMARY | Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS) | S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days]) | Safety population included all participants who had received at least 1 dose of the study medication. | participants | NUMBER |
| PRIMARY | Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS) | S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days]) | Safety population included all participants who had received at least 1 dose of the study medication. | cycles | NUMBER |
| PRIMARY | Number of Participants With Adverse Events (AEs) | S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days]) | Safety population included all participants who had received at least 1 dose of the study medication. | participants | NUMBER |
| SECONDARY | Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day | r-hCG day (end of stimulation cycle [approximately 9 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. | follicles | MEAN |
| SECONDARY | Endometrial Thickness on Recombinant Human Choriogonadotropin (r-hCG) Day | r-hCG day (end of stimulation cycle [approximately 9 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure. | mm | MEAN |
| SECONDARY | Number of Fertilized Oocytes (2 Pronuclei [PN]) | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up. | 2PN oocytes | NUMBER |
| SECONDARY | Number of Fertilized Oocytes at Stage 2 Pronuclei (2PN) or Higher Than 2PN | Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up. | oocytes | NUMBER |
| SECONDARY | Number and Quality of Embryos | Day 2-3 post OPU (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who continued with follicular development. | embryos | NUMBER |
| SECONDARY | Implantation Rate | Day 35-42 post OPU (34-38 hours post r-hCG day {end of stimulation cycle [approximately 9 days]}) | ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure. | percent sacs per embryo | MEAN |
| SECONDARY | Number of Participants With Clinical Pregnancies | Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. | participants | NUMBER |
| SECONDARY | Number of Participants in Whom Recombinant Human Chorionic Gonadotropin (r-hCG) Was Not Administered Due to Poor Response | r-hCG day (end of stimulation cycle [approximately 9 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. | participants | NUMBER |
| SECONDARY | Number of Ovarian Stimulation Days | Day 1 of stimulation period (S1) up to r-hCG day (end of stimulation cycle [approximately 9 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. | days | MEAN |
| SECONDARY | Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH) | Day 1 of stimulation period (S1) up to r-hCG day (end of stimulation cycle [approximately 9 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. | IU | MEAN |
| SECONDARY | Estradiol (E2) Levels on r-hCG Day | r-hCG day (end of stimulation cycle [approximately 9 days]) | ITT population included all randomized participants who had received at least 1 dose of the study medication.N (number of participants analyzed) signifies those participants with plasma E2 levels at r-hCG day. | picogram/milliter (pg/mL) | MEAN |
| SECONDARY | Follicular Levels of Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and Human Chorionic Gonadotropin (hCG) at Ovum Pick up (OPU) | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure. | milli international unit (mIU)/mL | MEAN |
| SECONDARY | Follicular Levels of Estradiol (E2) at Ovum Pick up (OPU) | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure. | pg/mL | MEAN |
| SECONDARY | Follicular Levels of Testosterone (T) at Ovum Pick up (OPU) | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) | ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure. | nanogram/milliliter (ng/mL) | 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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