Trial · NCT01687712
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population | Six weeks post embryo transfer | Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the ITT population of the respective treatment arm. |
| Primary | Clinical Pregnancy Rate After One Cycle of Treatment - PP Population | Six weeks post embryo transfer | Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the PP population of the respective treatment arm. |
| Secondary | Exposure to r-hFSH Injections: Days of r-hFSH Stimulation - Cycle 1 | Measured at discretionary visits between Days 9 and 15 after FSH starts | The number of days of r-hFSH stimulation a subject received during Cycle 1. |
| Secondary | Exposure to r-hFSH Injections: Total Dose of r-hFSH (IU) - Cycle 1 | Measured at discretionary visits between Days 9 and 15 after FSH starts. | The total dose of r-hFSH that subjects received during Cycle 1. |
| Secondary | Exposure to r-hFSH Injections: Daily Dose of r-hFSH (IU) - Cycle 1 | Measured at discretionary visits between Days 9 and 15 after FSH starts. | The mean dose of r-hFSH that subjects received in a day during Cycle 1. |
| Secondary | Number of Oocytes Retrieved - Cycle 1 | Visit 8, 34-36 hours after hCG administration | The number of oocytes retrieved per subject, following hCG administration in Cycle 1. |
| Secondary | Local and Systemic Adverse Events: Dermal Response to Injection - Cycle 1 | Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH Start through to Day 16 after start of FSH (16 days). | Number of subjects reporting at least one dermal response to r-hFSH injection and number of subjects reporting no dermal responses. |
| Secondary | Local and Systemic Adverse Events: Dermal Response to Injection by Severity - Cycle 1 | Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH through to Day 16 after start of FSH (16 days). | Dermal response to r-hFSH injection as assessed by the investigator and categorized according to severity of reaction |
| Secondary | Overall Summary of Adverse Events (AEs) - Cycle 1 | Measured from the start of FSH treatment through to either the end FSH treatment + 30 days (up to 46 days) or to the last Telephone Follow-up / Live Birth Questionnaire on pregnancy outcome (if applicable) (up to 10 months). | Summary of AEs, including the number of subjects experiencing to following during Cycle 1: At least one AE At least one treatment related AE At least one serious AE At least one AE leading to discontinuation of study drug At least one AE due to pregnancy complication |
| Secondary | Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 1 | Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10). | Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included. |
| Secondary | Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 2 | Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10). | Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included. |
| Secondary | Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 3 | Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10). | Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included. |
| Secondary | Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 1 | Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer). | Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 1. |
| Secondary | Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 2 | Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer). | Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 2. |
| Secondary | Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 3 | Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer). | Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 3. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT01687712/registered