Trial · NCT02310919
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Fertilization Proportion (i.e. Total Competent Proportion) | 2 days | The number of fertilized oocytes (2-pronuclei) after standard in vitro fertilization or intra-cytoplasmic sperm injection divided by the total number of oocytes retrieved as a measure of oocyte competence. |
| Secondary | Number of Oocytes Retrieved | 1 day | The total number of oocytes recovered at the oocyte retrieval. |
| Secondary | Number of MII Oocytes | 1 day | The number of metaphase 2 oocytes (MII) recovered which can only be calculated in patients that underwent intracytoplasmic sperm injection. |
| Secondary | Total Oocyte Maturity Rate | 1 day | Oocyte maturity rate was determined by the number of meta phase 2 (MII) oocytes divided by the number of oocytes retrieved. This outcome was only assessed in patients undergoing intracytoplasmic sperm injection (ICSI). |
| Secondary | Mature Oocyte Recovery Proportion | 1 day | Mature oocyte recovery proportion is defined as the number of MIIs divided by the total number of follicles greater or equal to 13mm in size on trigger day. |
| Secondary | ICSI Fertilization Rate | 2 days | ICSI fertilization rate was determined by the number of 2 pro-nuclei (2PN) divided by the number of MII oocytes. This was only assessed in patients undergoing ICSI. |
| Secondary | High Quality Cleavage-stage Embryos | 4 days | Good quality embryo development was compared between trigger groups by calculating the ratio of good quality embryos to the total number of cleavage-stage embryos. A good quality cleavage-stage embryo was defined by having a cell number of 7 to 10 and \<10% of cell fragmentation based on a modified Veeck's grading system. |
| Secondary | High Quality Blastocyst Embryos | 6 days | A high quality blastocyst was defined as grade 3 or higher expansion plus inner cell mass and trophectoderm grading of A or B based on Gardner's criteria. The number describes the degree of embryo expansion on a scale from 1-6. As the embryo expands, the degree of expansion increases. The first letter indicates on a scale from A to C (A being the highest) the quality of the inner cell mass. The second letter is also on a scale from A to C (A being the highest) and indicates the quality of the trophectoderm. |
| Secondary | Livebirth Rate From All Fresh Transfers | 10 months | Livebirth rate (LBR) was defined as a liveborn at the time of the analysis. Pregnancy outcomes were calculated for all fresh transfers. |
| Secondary | Bloating Score | about 16 days (varies by subject), accounts for the median length of IVF stimulation in this study being 11 days from baseline to 5 days post trigger | Change in bloating scores from day of baseline ultrasound to post-trigger day 5. The patient's clinical symptoms will be evaluated based on a bloating score reported by each patient on the day of ovulation trigger and then 5 days after the oocyte retrieval will be determined. The bloating score will range on a scale from 0-5. The number describes the degree of bloating and will increase as the degree of bloating increases. The bloating score will be determined as follows: 0 - No bloating 1. \- Mild bloating. Able to continue daily activities without discomfort. 2. \- Mild to moderate bloating. Able to continue daily activities but with mild discomfort. 3. \- Moderate bloating. Able to continue daily activities but with moderate discomfort. 4. \- Moderate to severe bloating. Difficulty performing daily activities. 5. \- Severe bloating. Abdomen feels very tense and unable to perform daily activities. |
| Secondary | Abdominal Circumference | about 16 days (varies by subject), accounts for the median length of IVF stimulation in this study being 11 days from baseline to 5 days post trigger | Change in abdominal circumference (in centimeters) from day of baseline ultrasound to post-trigger day 5. |
| Secondary | Body Weight | about 16 days (varies by subject), accounts for the median length of IVF stimulation in this study being 11 days from baseline to 5 days post trigger | Change in body weight from day of baseline ultrasound to post-trigger day 5. |
| Secondary | Serum hCG T+1 | 1 day | Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of human chorionic gonadotropin (hCG). |
| Secondary | Serum FSH T+1 | 1 day | Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of follicle stimulating hormone (FSH). |
| Secondary | Serum P4 on T+1 | 1 day | Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of Progesterone (P4). |
| Secondary | Serum E2 on T+1 | 1 day | Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of estradiol (E2). |
| Secondary | Serum LH on T+1 | 1 day | Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of luteinizing hormone (LH). |
| Secondary | Serum hCG on T+2 | 2 days | Blood samples were collected about 2 days after trigger (T+2) to assess the serum concentration of human chorionic gonadotropin (hCG). |
| Secondary | Serum FSH on T+2 | 2 days | Blood samples were collected 2 days after trigger (T+2) to assess the serum concentration of follicle stimulating hormone (FSH). |
| Secondary | Serum P4 on T+2 | 2 days | Blood samples were collected 2 days after trigger (T+2) to assess the serum concentration of progesterone (P4). |
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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