| Primary | Total Fertilization Proportion (i.e. Total Competent Proportion) | 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. | | Posted | | Mean | Standard Error | ratio | | 2 days | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0000.59± 0.029
- OG0010.65± 0.024
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The alternative trigger will be considered non-inferior to the standard hCG trigger if it is at least 80% as effective at inducing oocyte competence. Considering a cluster size of 15 oocytes and an estimated intra-cluster correlation of 0.1, we calculated that approximately 50 participants were needed in each study arm when the non-inferiority difference is -0.1 (i.e. 20% of 0.5 total competent proportion) with a power of 0.8 and a one-sided alpha of 0.05. | log-binomial regression with GEE | | | Using the standard trigger as the reference, the relative risk (i.e. risk ratio) (RR) with 95% confidence interval (CI) for the probability of the outcome was calculated using log-binomial regression models with application of GEE. | Risk Ratio (RR) | 0.91 | | | 1-Sided | 95 | 0.83 | | | | |
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| Secondary | Number of Oocytes Retrieved | The total number of oocytes recovered at the oocyte retrieval. | No outcome data for 1 participant that elected to convert to intrauterine insemination after trigger | Posted | | Mean | Standard Error | oocytes | | 1 day | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously. |
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| Secondary | Number of MII Oocytes | The number of metaphase 2 oocytes (MII) recovered which can only be calculated in patients that underwent intracytoplasmic sperm injection. | This parameter can only be calculated in patients that underwent oocyte stripping to undergo intracytoplasmic sperm injection for fertilization method. | Posted | | Mean | Standard Error | MII oocytes | | 1 day | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously. |
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| Secondary | Total Oocyte Maturity Rate | 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). | This parameter can only be calculated in patients that underwent oocyte stripping to undergo intracytoplasmic sperm injection for fertilization method. | Posted | | Mean | Standard Error | ratio of MII oocytes | | 1 day | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously. |
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| Secondary | Mature Oocyte Recovery Proportion | 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. | This parameter can only be calculated in patients that underwent oocyte stripping to undergo intracytoplasmic sperm injection for fertilization method. | Posted | | Mean | Standard Error | ratio | | 1 day | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously. |
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| Secondary | ICSI Fertilization Rate | 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. | This parameter can only be calculated in patients that were undergoing intracytoplasmic sperm injection for fertilization method. One participant the low dose hCG plus FSH co-trigger arm was not included in the analysis as they underwent oocyte cryopreservation instead as the male partner was unable to produce fresh sperm sample to fertilize the oocytes. | Posted | | Mean | Standard Error | ratio of fertilized oocytes | | 2 days | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously. |
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| Secondary | High Quality Cleavage-stage Embryos | 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. | No outcome data for 3 participants: 1) participant that elected to convert to intrauterine insemination after trigger; 2) participant that underwent oocyte cryopreservation due to male partner being unable to produce fresh sperm sample for fertilization; 3) cleavage-stage embryo quality was inadvertently not documented by the staff embryologist in one participant | Posted | | Mean | Standard Error | ratio of good quality embryos | | 4 days | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously. |
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| Secondary | High Quality Blastocyst Embryos | 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. | | Posted | | Mean | Standard Error | ratio of good quality embryos | | 6 days | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously. |
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| Secondary | Livebirth Rate From All Fresh Transfers | Livebirth rate (LBR) was defined as a liveborn at the time of the analysis. Pregnancy outcomes were calculated for all fresh transfers. | Only patients that underwent a fresh embryo transfer can be included in this analysis. Not all participants underwent fresh embryo transfers. | Posted | | Number | | live births | | 10 months | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously. |
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| Secondary | Bloating Score | 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
- - Mild bloating. Able to continue daily activities without discomfort.
- - Mild to moderate bloating. Able to continue daily activities but with mild discomfort.
- - Moderate bloating. Able to continue daily activities but with moderate discomfort.
- - Moderate to severe bloating. Difficulty performing daily activities.
- - Severe bloating. Abdomen feels very tense and unable to perform daily activities.
| Only patients that answered this question on the study questionnaire could be included in this analysis. | Posted | | Median | Inter-Quartile Range | score on a scale | | 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 | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | |
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| Secondary | Abdominal Circumference | Change in abdominal circumference (in centimeters) from day of baseline ultrasound to post-trigger day 5. | Only patients that had their abdominal circumference measured on both day of baseline ultrasound and post-trigger day 5 could be included in this analysis. | Posted | | Median | Inter-Quartile Range | centimeters | | 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 | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously. |
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| Secondary | Body Weight | Change in body weight from day of baseline ultrasound to post-trigger day 5. | Only patients that had their body weight measured on both day of baseline ultrasound and post-trigger day 5 could be included in this analysis. | Posted | | Median | Inter-Quartile Range | difference in kilograms | | 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 | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously. |
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| Secondary | Serum hCG T+1 | Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of human chorionic gonadotropin (hCG). | Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population. | Posted | | Median | Inter-Quartile Range | IU/L | | 1 day | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of 10,000 IU hCG subcutaneously. |
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| Secondary | Serum FSH T+1 | Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of follicle stimulating hormone (FSH). | Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population. | Posted | | Median | Inter-Quartile Range | mIU/ml | | 1 day | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of 10,000 IU hCG subcutaneously. |
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| Secondary | Serum P4 on T+1 | Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of Progesterone (P4). | Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population. | Posted | | Median | Inter-Quartile Range | ng/ml | | 1 day | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of 10,000 IU hCG subcutaneously. |
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| Secondary | Serum E2 on T+1 | Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of estradiol (E2). | Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population. | Posted | | Median | Inter-Quartile Range | pg/ml | | 1 day | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of 10,000 IU hCG subcutaneously. |
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| Secondary | Serum LH on T+1 | Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of luteinizing hormone (LH). | Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population. | Posted | | Median | Inter-Quartile Range | mIU/ml | | 1 day | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of 10,000 IU hCG subcutaneously. |
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| Secondary | Serum hCG on T+2 | Blood samples were collected about 2 days after trigger (T+2) to assess the serum concentration of human chorionic gonadotropin (hCG). | Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population. | Posted | | Median | Inter-Quartile Range | IU/L | | 2 days | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of 10,000 IU hCG subcutaneously. |
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| Secondary | Serum FSH on T+2 | Blood samples were collected 2 days after trigger (T+2) to assess the serum concentration of follicle stimulating hormone (FSH). | Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population. | Posted | | Median | Inter-Quartile Range | mIU/ml | | 2 days | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of 10,000 IU hCG subcutaneously. |
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| Secondary | Serum P4 on T+2 | Blood samples were collected 2 days after trigger (T+2) to assess the serum concentration of progesterone (P4). | Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population. | Posted | | Median | Inter-Quartile Range | ng/ml | | 2 days | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of 10,000 IU hCG subcutaneously. |
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| Secondary | Serum E2 on T+2 | Blood samples were collected 2 days after trigger (T+2) to assess the serum concentration of estradiol (E2). | Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population. | Posted | | Median | Inter-Quartile Range | pg/ml | | 2 days | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of 10,000 IU hCG subcutaneously. |
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| Secondary | Serum HCG on T+5 | Blood samples were collected 5 days after trigger (T+5) to assess the serum concentration of human chorionic gonadotropin (hCG). | Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population. | Posted | | Median | Inter-Quartile Range | IU/L | | 5 days | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of 10,000 IU hCG subcutaneously. |
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| Secondary | Serum FSH on T+5 | Blood samples were collected 5 days after trigger (T+5) to assess the serum concentration of follicle stimulating hormone (FSH). | Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population. | Posted | | Median | Inter-Quartile Range | mIU/ml | | 5 days | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of 10,000 IU hCG subcutaneously. |
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| Secondary | Serum LH on T+5 | Blood samples were collected about 5 days after trigger (T+5) to assess the serum concentration of luteinizing hormone (LH). | Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population. | Posted | | Median | Inter-Quartile Range | mIU/ml | | 5 days | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of 10,000 IU hCG subcutaneously. |
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| Secondary | Follicular hCG | Follicular fluid was individually aspirated at oocyte retrieval from the lead follicle in each ovary using a single lumen needle. The mean concentration between right and left follicles collected was compared to assess the follicular concentration of human chorionic gonadotropin (hCG). | Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population. | Posted | | Median | Inter-Quartile Range | IU/L | | 2 days | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of 10,000 IU hCG subcutaneously. |
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| Secondary | Follicular FSH | Follicular fluid was individually aspirated at oocyte retrieval from the lead follicle in each ovary using a single lumen needle. The mean concentration between right and left follicles collected was compared to assess the follicular concentration of follicle stimulating hormone (FSH). | Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population. | Posted | | Median | Inter-Quartile Range | mIU/ml | | 2 days | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of 10,000 IU hCG subcutaneously. |
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| Secondary | Follicular P4 | Follicular fluid was individually aspirated at oocyte retrieval from the lead follicle in each ovary using a single lumen needle. The mean concentration between right and left follicles collected was compared to assess the follicular concentration of progesterone (P4). | | Posted | | Median | Inter-Quartile Range | ng/ml | | 2 days | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of 10,000 IU hCG subcutaneously. |
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| Secondary | Follicular E2 | Follicular fluid was individually aspirated at oocyte retrieval from the lead follicle in each ovary using a single lumen needle. The mean concentration between right and left follicles collected was compared to assess the follicular concentration of estradiol (E2). | Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population. | Posted | | Median | Inter-Quartile Range | pg/ml | | 2 days | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of 10,000 IU hCG subcutaneously. |
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| Secondary | Follicular VEGF | Follicular fluid was individually aspirated at oocyte retrieval from the lead follicle in each ovary using a single lumen needle. The mean concentration between right and left follicles collected was compared to assess the follicular concentration of vascular endothelial growth factor (VEGF). | Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population. | Posted | | Median | Inter-Quartile Range | pg/ml | | 2 days | | | | ID | Title | Description |
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| OG000 | Low Dose hCG Plus FSH Co-trigger | On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | | OG001 | Standard Dose of hCG Alone | On the day of ovulation trigger the patient will receive standard dose of 10,000 IU hCG subcutaneously. |
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