Trial · NCT01079949
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Oocytes Retrieved | Ovum pick-up (OPU) day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) | 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. |
| Primary | Number of Mature Oocytes Retrieved | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) | Number of mature oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day) 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 is assessed based on the presence of a germinal vesicle (GV) or whether oocytes were in metaphase I (Meta-I) or II (Meta-II) stage or atretic. |
| Primary | Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS) | S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 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. |
| Primary | Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS) | S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 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. |
| Primary | Number of Participants With Adverse Events (AEs) | S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 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 | 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 9 days]) | |
| Secondary | Endometrial Thickness on Recombinant Human Choriogonadotropin (r-hCG) Day | r-hCG day (end of stimulation cycle [approximately 9 days]) | Endometrial thickness measurement was performed on the day of r-hCG administration. |
| Secondary | Number of Fertilized Oocytes (2 Pronuclei [PN]) | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 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 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 of Fertilized Oocytes at Stage 2 Pronuclei (2PN) or Higher Than 2PN | Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 days]) | Oocytes were fertilized using 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 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. Fertilized oocytes at stage higher then 2PN are those oocytes which consist more than 2 pronuclei like oocyte having 3 pronuclei termed as 3PN, oocyte having 4 pronuclei termed as 4PN. |
| Secondary | Number and Quality of Embryos | Day 2-3 post OPU (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) | Embryos were classified into 5 different grades (1 to 5) based on their capacity of implantation. Grade 1 embryos were those with best capacity of implantation and Grade 5 embryos were those with worst capacity of implantation. |
| Secondary | Implantation Rate | Day 35-42 post OPU (34-38 hours post r-hCG day {end of stimulation cycle [approximately 9 days]}) | Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100. |
| Secondary | Number of Participants With Clinical Pregnancies | Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 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 | Number of Participants in Whom Recombinant Human Chorionic Gonadotropin (r-hCG) Was Not Administered Due to Poor Response | r-hCG day (end of stimulation cycle [approximately 9 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 | Number of Ovarian Stimulation Days | Day 1 of stimulation period (S1) up to r-hCG day (end of stimulation cycle [approximately 9 days]) | Ovarian stimulation included from first r-hFSH injection (S1) until day on which r-hCG was administered (r-hCG day). |
| Secondary | Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH) | Day 1 of stimulation period (S1) up to r-hCG day (end of stimulation cycle [approximately 9 days]) | |
| Secondary | Estradiol (E2) Levels on r-hCG Day | r-hCG day (end of stimulation cycle [approximately 9 days]) | |
| Secondary | Follicular Levels of Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and Human Chorionic Gonadotropin (hCG) at Ovum Pick up (OPU) | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) | |
| Secondary | Follicular Levels of Estradiol (E2) at Ovum Pick up (OPU) | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}]) | |
| Secondary | Follicular Levels of Testosterone (T) at Ovum Pick up (OPU) | OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 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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