Trial · NCT01497197
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Number of Oocytes Retrieved Per Subject Following Ovarian Stimulation | 34-38 hours post r-hCG administration | Ovarian stimulation was performed using in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The total number of oocytes collected per subject following stimulation was reported. |
| Secondary | Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH) | Screening | Mean daily dose of FSH was to be determined by dividing the total daily dose by the number of stimulation days. |
| Secondary | Total Number of Stimulation Treatment Days | 6 days post stimulation (Number of stimulation days+6 days) | The total number of stimulation treatment days for each subject was determined based on the treatment administration information collected in the case report form. |
| Secondary | Implantation Rate | 35-42 days post r-hCG administration | The implantation rate was determined as number of fetal sacs divided by the number of embryos transferred post r-hCG administration. |
| Secondary | Number of Fetal Sacs With Activity | 35-42 days post r-hCG administration | Number of fetal sacs with activity was evaluated by ultrasound scan (US) on Days 35-42 post r-hCG to confirm clinical pregnancy. |
| Secondary | Number of Fetal Sacs With Detectable Heart Beats | 35-42 days post r-hCG administration | Number of fetal sacs with detectable heart beats was evaluated by US on Days 35-42 post r-hCG to confirm clinical pregnancy |
| Secondary | Total Pregnancy Rate and Clinical Pregnancy Rate | 35-42 days post r-hCG administration | The subject was considered to have a positive pregnancy result if beta-hCG \>10 international units per liter (IU/L) and the subject had not menstruated between post-r-hCG Days 15-20. Clinical pregnancy was defined as the existence of at least an US confirmed gestational sac in the uterus with fetal heart activity post-r-hCG Days 35-42. |
| Secondary | Cycle Cancellation Rate Prior to r-hCG | Up to 85 days | If the subject was not administered with r-hCG and withdrew prematurely from the trial, it was considered as cycle cancellation. |
| Secondary | Number of Subjects With Biochemical Pregnancies | 35 to 42 days post r-hCG administration | Biochemical pregnancy was defined as the pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. Subjects with beta-hCG concentration greater than 10 IU/L were considered as biochemical pregnant. |
| Secondary | Number of Subjects With Multiple Pregnancies | 35 to 42 days post r-hCG administration | Multiple pregnancy was defined as the existence of more than one ultrasound confirmed gestational sac in the uterus with fetal heart activity at post-r-hCG Days 35-42. |
| Secondary | Number of Subjects With Any Adverse Events (AEs), Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation | Baseline up to 15-20 days post r-hCG administration | An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. |
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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GET https://conductscience.org/api/trials/v1/NCT01497197/registered