Trial · NCT01297465
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Number of Oocytes Retrieved | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 11 days}]) | The total number of oocytes retrieved per reporting group on the day of ovum pick-up (OPU) (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body. |
| 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]) | |
| Secondary | Total Number of Stimulation Treatment Days | Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days]) | |
| Secondary | Implantation Rate | Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) | Implantation rate per reporting group was measured as the number of fetal sacs observed, divided by the number of embryos transferred multiplied by 100. |
| Secondary | Number of Fetal Sacs With Activity | Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}]) | Number of fetal sacs with activity was evaluated by ultrasound scan |
| Secondary | Number of Fetal Hearts With Activity | Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}]) | Number of fetal hearts with activity was evaluated by ultrasound scan |
| Secondary | Clinical Pregnancy Rate | Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) | Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Clinical pregnancy rate was reported as total clinical pregnancy rate, clinical pregnancy rate per cycle started and per embryo transfer \[ET\]). |
| 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]) | An excessive ovarian response: greater than or equal to 25 oocytes which could put the participant at risk of OHSS; An insufficient ovarian response: defined as 3 or less follicles of greater than or equal to 12 millimeter developing following at least 7 days of treatment. |
| Secondary | Biochemical Pregnancies Rate | Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) | Biochemical pregnancy was defined as the pregnancy diagnosed only by the detection of human chorionic gonadotropin (hCG) in serum or urine and that does not develop into a clinical pregnancy. Participants with beta- hCG concentration greater than 10 international units per liter (IU/L) were considered as biochemical pregnant. |
| Secondary | Number of Participants With Multiple Pregnancies | Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) | Multiple pregnancy was defined as the existence of more than one fetal sac with fetal heart activity. |
| 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]) | Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting. Early OHSS was defined as the onset of OHSS occurring within 9 days after oocyte retrieval and late OHSS was defined as the onset of OHSS occurring on or after day 10 from oocyte retrieval. |
| 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]) | An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. |
| Secondary | Systolic and Diastolic Arterial Blood Pressure Assessments | Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) | |
| Secondary | Heart Rate Assessments | Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) |
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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