Trial · NCT01075815
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Implantation Rate | Day 35-42 post ovum pick-up (OPU) (34-38 hours post recombinant human choriogonadotropin day {end of stimulation cycle}[approximately 28 days]) | Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred. |
| Secondary | Mean 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 28 days]) | |
| Secondary | Mean Number of Oocytes Retrieved | 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) | Mean number of oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle \[approximately 28 days\]) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. |
| Secondary | Number of Mature Oocytes Retrieved | 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) | Number of mature oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle \[approximately 28 days\]) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The nuclear maturity was evaluated based on the presence of a germinal vesicle (GV) or whether oocytes were in metaphase I (Meta-I) or II (Meta-II) stage. |
| Secondary | Number of Fertilized Oocytes (2 Pronuclei [PN]) | 34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) | Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of two 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN. |
| Secondary | Number and Quality of Embryos | Day 2-3 post OPU (34-38 hours post r-hCG day {end of stimulation cycle}[approximately 28 days]) | Embryos were graded according to Spanish Association for the Study of Reproductive Biology (ASEBIR) criteria into different categories: (A) optimal quality with maximum capacity for implantation, (B) good quality with a high capacity for implantation, (C) regular with low possibility of implantation and (D) poor quality with very little possibility of implantation. |
| Secondary | Number of Participants With Biochemical Pregnancies | 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. |
| Secondary | Number of Participants With Clinical Pregnancies | 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 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. |
| Secondary | Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH) | 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | |
| Secondary | Estradiol (E2) Levels on r-hCG Day | r-hCG day (end of stimulation cycle [approximately 28 days]) | |
| Secondary | Number of Ovarian Stimulation Days | S1 up to r-hCG day (end of stimulation cycle [approximately 28 days]) | Ovarian stimulation included from first rFSH injection (S1) until day on which r-hCG was administered (r-hCG day). This period was divided into 2 parts: the first period in which 300 International Unit (IU) rFSH dose was constant and which covered from S1 to Day 4 of stimulation period (S4); the second period in which the rFSH dose could be adjusted depending on the ovarian response and which began on S4 and finished on the day on which the criteria for administration of r-hCG to induce the final follicular maturation were met. |
| Secondary | Number of Recombinant Human Choriogonadotropin (r-hCG) Cycles Cancelled Due to Poor Response | Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | Poor response was defined as 3 or less follicles of greater than or equal to 12 mm developing following at least 7 days of study treatment. |
| Secondary | Total Number of Births | Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | Total number of births per reporting group was calculated. |
| Secondary | Number of Participants With Adverse Events (AEs) | Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
| Secondary | Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS) | Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting. |
| Secondary | Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS) | Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days]) | OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting. |
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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