Trial · NCT03296527
Outcomes61
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 61
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ongoing Pregnancy Rate | 10-11 weeks after transfer | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | percentage of participants | NUMBER |
| SECONDARY | Positive Beta Unit of Human Chorionic Gonadotropin (βhCG) Rate | 13-15 days after transfer | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | percentage of participants | NUMBER |
| SECONDARY | Clinical Pregnancy Rate | 5-6 weeks after transfer | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | percentage of participants | NUMBER |
| SECONDARY | Vital Pregnancy Rate | 5-6 weeks after transfer | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | percentage of participants | NUMBER |
| SECONDARY | Implantation Rate | 5-6 weeks after transfer | Participants with embryo transfer (a total of 548 and 546 embryos were transferred in the FE 999049 and GONAL-F groups, respectively). The experimental unit was transferred embryo. | percentage of sacs/embryos transferred | NUMBER |
| SECONDARY | Ongoing Implantation Rate | 10-11 weeks after transfer | Participants with embryo transfer (a total of 548 and 546 embryos were transferred in the FE 999049 and GONAL-F groups, respectively). The experimental unit was transferred embryos. | % of viable fetus/embryos transferred | NUMBER |
| SECONDARY | Proportion of Subjects With Extreme Ovarian Responses | Oocyte retrieval visit | The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants with oocytes retrieved and participants with cycle cancellation due to poor ovarian response. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS | Up to 9 days after triggering of final follicular maturation | The safety analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment received. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Subjects With Cycle Cancellation Due to Poor or Excessive Ovarian Response or Embryo Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk | End-of-stimulation visit (up to 20 days) or transfer visit | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | percentage of participants | NUMBER |
| SECONDARY | Number of Follicles on Stimulation Day 6 | On stimulation Day 6 | The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | number of follicles | MEAN |
| SECONDARY | Number of Follicles At End-of-stimulation (up to 20 Stimulation Days) | At end-of-stimulation (up to 20 stimulation days) | The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | number of follicles | MEAN |
| SECONDARY | Size of Follicles on Stimulation Day 6 | On stimulation Day 6 | The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | mm | MEAN |
| SECONDARY | Size of Follicles At End-of-stimulation (up to 20 Stimulation Days) | At end-of-stimulation (up to 20 stimulation days) | The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure. | mm | MEAN |
| SECONDARY | Number of Oocytes Retrieved | On the day of oocyte retrieval (36 h [±2h] after triggering of final follicular maturation) | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | oocytes retrieved | MEAN |
| SECONDARY | Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved | On the day of oocyte retrieval | The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants with oocytes retrieved and participants with cycle cancellation due to poor ovarian response. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Metaphase II (MII) Oocytes | Prior to insemination | The FAS was defined as all randomized and exposed participants. Participants analyzed for this endpoint represent participants with all oocytes inseminated using ICSI. | percentage of oocytes | MEAN |
| SECONDARY | Fertilization Rate | On Day 1 after oocyte retrieval | Participants with oocytes retrieved. | percentage of fertilized oocytes | MEAN |
| SECONDARY | Number and Quality of Embryos | On Day 3 after oocyte retrieval | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | embryos | MEAN |
| SECONDARY | Circulating Concentrations of Luteinizing Hormone (LH) | On stimulation Day 6 | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | IU/L | MEDIAN |
| SECONDARY | Circulating Concentrations of LH | End-of-stimulation (up to 20 stimulation days) | The FAS was defined as all randomized and exposed participants. Participants were analyzed according to randomized treatment. | IU/L | MEDIAN |
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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