Trial Outcomes & Findings for Administration of Follicle-stimulating Hormone (FSH) and Low Dose Human Chorionic Gonadotropin (hCG) for Oocyte Maturity While Decreasing hCG Exposure in In Vitro Fertilization (IVF) Cycles (NCT NCT02310919)
NCT ID: NCT02310919
Last Updated: 2022-04-29
Results Overview
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.
COMPLETED
PHASE3
105 participants
2 days
2022-04-29
Participant Flow
Sixteen patients were excluded prior to starting their IVF cycle (i.e., 9 withdrew and 7 became spontaneously pregnant), and 15 were excluded prior to randomization due to cycle cancellation for poor response or having an E2 \>5,000 pg/ml on T+0.
Participant milestones
| Measure |
Low Dose hCG Plus FSH Co-trigger
On the day of ovulation trigger the patient will receive hCG 1,500 IU SQ plus FSH 450 IU SQ
Low dose hCG plus FSH co-trigger: Low dose hCG (1,500 IU) plus FSH (450 IU) co-trigger
|
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 SQ)
Standard dose of hCG: Standard dose of hCG (10,000 or 5,000 IU) trigger
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
51
|
|
Overall Study
COMPLETED
|
54
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=54 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=51 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.5 years
n=54 Participants
|
37.0 years
n=51 Participants
|
37.0 years
n=105 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=54 Participants
|
51 Participants
n=51 Participants
|
105 Participants
n=105 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=54 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=105 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index
|
22.8 kg/m^2
n=54 Participants
|
22.8 kg/m^2
n=51 Participants
|
22.8 kg/m^2
n=105 Participants
|
|
Baseline antral follicle count (AFC)
|
14.5 follicles
n=54 Participants
|
15.0 follicles
n=51 Participants
|
15.0 follicles
n=105 Participants
|
|
Number of prior IVF attempts
|
1.0 IVF cycles
n=54 Participants
|
1.0 IVF cycles
n=51 Participants
|
1.0 IVF cycles
n=105 Participants
|
|
Infertility Diagnosis
Unexplained
|
23 Participants
n=54 Participants
|
24 Participants
n=51 Participants
|
47 Participants
n=105 Participants
|
|
Infertility Diagnosis
Male factor
|
7 Participants
n=54 Participants
|
11 Participants
n=51 Participants
|
18 Participants
n=105 Participants
|
|
Infertility Diagnosis
Tubal factor
|
3 Participants
n=54 Participants
|
2 Participants
n=51 Participants
|
5 Participants
n=105 Participants
|
|
Infertility Diagnosis
Other
|
21 Participants
n=54 Participants
|
14 Participants
n=51 Participants
|
35 Participants
n=105 Participants
|
|
Total dose of gonadotropins
|
3750.0 International Units (IU)
n=54 Participants
|
3375.0 International Units (IU)
n=51 Participants
|
3525.0 International Units (IU)
n=105 Participants
|
|
Length of stimulation
|
11.0 days
n=54 Participants
|
11.0 days
n=51 Participants
|
11.0 days
n=105 Participants
|
|
Number of follicles on T+0
|
18.5 follicles
n=54 Participants
|
17.0 follicles
n=51 Participants
|
18.0 follicles
n=105 Participants
|
|
Serum estradiol on T+0
|
2871.0 pg/ml
n=54 Participants
|
2911.0 pg/ml
n=51 Participants
|
2883.0 pg/ml
n=105 Participants
|
PRIMARY outcome
Timeframe: 2 daysThe 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.
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=54 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=51 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Total Fertilization Proportion (i.e. Total Competent Proportion)
|
0.59 ratio
Standard Error 0.029
|
0.65 ratio
Standard Error 0.024
|
SECONDARY outcome
Timeframe: 1 dayPopulation: No outcome data for 1 participant that elected to convert to intrauterine insemination after trigger
The total number of oocytes recovered at the oocyte retrieval.
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=53 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=51 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Number of Oocytes Retrieved
|
13.6 oocytes
Standard Error 0.84
|
16.1 oocytes
Standard Error 1.01
|
SECONDARY outcome
Timeframe: 1 dayPopulation: This parameter can only be calculated in patients that underwent oocyte stripping to undergo intracytoplasmic sperm injection for fertilization method.
The number of metaphase 2 oocytes (MII) recovered which can only be calculated in patients that underwent intracytoplasmic sperm injection.
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=39 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=44 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Number of MII Oocytes
|
10.8 MII oocytes
Standard Error 0.74
|
12.5 MII oocytes
Standard Error 0.81
|
SECONDARY outcome
Timeframe: 1 dayPopulation: This parameter can only be calculated in patients that underwent oocyte stripping to undergo intracytoplasmic sperm injection for fertilization method.
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).
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=39 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=44 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Total Oocyte Maturity Rate
|
0.75 ratio of MII oocytes
Standard Error 0.021
|
0.77 ratio of MII oocytes
Standard Error 0.020
|
SECONDARY outcome
Timeframe: 1 dayPopulation: This parameter can only be calculated in patients that underwent oocyte stripping to undergo intracytoplasmic sperm injection for fertilization method.
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.
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=39 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=44 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Mature Oocyte Recovery Proportion
|
0.81 ratio
Standard Error 0.032
|
0.92 ratio
Standard Error 0.018
|
SECONDARY outcome
Timeframe: 2 daysPopulation: 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.
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.
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=38 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=44 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
ICSI Fertilization Rate
|
0.80 ratio of fertilized oocytes
Standard Error 0.032
|
0.80 ratio of fertilized oocytes
Standard Error 0.024
|
SECONDARY outcome
Timeframe: 4 daysPopulation: 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
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.
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=51 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=51 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
High Quality Cleavage-stage Embryos
|
0.59 ratio of good quality embryos
Standard Error 0.043
|
0.62 ratio of good quality embryos
Standard Error 0.027
|
SECONDARY outcome
Timeframe: 6 daysA 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.
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=35 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=40 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
High Quality Blastocyst Embryos
|
0.67 ratio of good quality embryos
Standard Error 0.044
|
0.68 ratio of good quality embryos
Standard Error 0.035
|
SECONDARY outcome
Timeframe: 10 monthsPopulation: Only patients that underwent a fresh embryo transfer can be included in this analysis. Not all participants underwent fresh embryo transfers.
Livebirth rate (LBR) was defined as a liveborn at the time of the analysis. Pregnancy outcomes were calculated for all fresh transfers.
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=32 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=28 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Livebirth Rate From All Fresh Transfers
|
15 live births
|
13 live births
|
SECONDARY outcome
Timeframe: 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 triggerPopulation: Only patients that answered this question on the study questionnaire could be included in this analysis.
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.
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=48 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=47 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Bloating Score
|
2.0 score on a scale
Interval 1.0 to 3.0
|
2.0 score on a scale
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: 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 triggerPopulation: 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.
Change in abdominal circumference (in centimeters) from day of baseline ultrasound to post-trigger day 5.
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=48 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=48 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Abdominal Circumference
|
0.38 centimeters
Interval -3.25 to 2.88
|
1.00 centimeters
Interval -2.0 to 4.88
|
SECONDARY outcome
Timeframe: 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 triggerPopulation: 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.
Change in body weight from day of baseline ultrasound to post-trigger day 5.
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=49 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=50 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Body Weight
|
0.10 difference in kilograms
Interval -0.35 to 0.7
|
0.05 difference in kilograms
Interval -0.53 to 0.53
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population.
Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of human chorionic gonadotropin (hCG).
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=50 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=35 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Serum hCG T+1
|
56.1 IU/L
Interval 39.0 to 65.6
|
267.4 IU/L
Interval 227.3 to 322.3
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population.
Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of follicle stimulating hormone (FSH).
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=50 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=35 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Serum FSH T+1
|
29.6 mIU/ml
Interval 24.0 to 34.3
|
19.0 mIU/ml
Interval 14.2 to 22.9
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population.
Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of Progesterone (P4).
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=50 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=35 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Serum P4 on T+1
|
6.1 ng/ml
Interval 4.2 to 8.5
|
7.0 ng/ml
Interval 5.4 to 11.1
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population.
Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of estradiol (E2).
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=50 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=35 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Serum E2 on T+1
|
4010 pg/ml
Interval 2612.0 to 4919.0
|
2763 pg/ml
Interval 1994.0 to 3341.0
|
SECONDARY outcome
Timeframe: 1 dayPopulation: Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population.
Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of luteinizing hormone (LH).
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=50 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=35 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Serum LH on T+1
|
1.75 mIU/ml
Interval 1.04 to 3.94
|
1.70 mIU/ml
Interval 0.66 to 3.96
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population.
Blood samples were collected about 2 days after trigger (T+2) to assess the serum concentration of human chorionic gonadotropin (hCG).
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=50 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=35 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Serum hCG on T+2
|
52.6 IU/L
Interval 40.6 to 62.0
|
271.3 IU/L
Interval 218.3 to 318.9
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population.
Blood samples were collected 2 days after trigger (T+2) to assess the serum concentration of follicle stimulating hormone (FSH).
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=50 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=35 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Serum FSH on T+2
|
20.5 mIU/ml
Interval 16.1 to 24.9
|
12.0 mIU/ml
Interval 9.7 to 14.1
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population.
Blood samples were collected 2 days after trigger (T+2) to assess the serum concentration of progesterone (P4).
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=50 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=35 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Serum P4 on T+2
|
10.7 ng/ml
Interval 7.4 to 13.9
|
10.0 ng/ml
Interval 6.9 to 13.9
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population.
Blood samples were collected 2 days after trigger (T+2) to assess the serum concentration of estradiol (E2).
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=50 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=35 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Serum E2 on T+2
|
1773 pg/ml
Interval 1304.0 to 2112.0
|
955 pg/ml
Interval 802.0 to 1205.0
|
SECONDARY outcome
Timeframe: 5 daysPopulation: Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population.
Blood samples were collected 5 days after trigger (T+5) to assess the serum concentration of human chorionic gonadotropin (hCG).
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=50 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=35 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Serum HCG on T+5
|
9.5 IU/L
Interval 5.9 to 12.5
|
52.1 IU/L
Interval 44.4 to 77.6
|
SECONDARY outcome
Timeframe: 5 daysPopulation: Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population.
Blood samples were collected 5 days after trigger (T+5) to assess the serum concentration of follicle stimulating hormone (FSH).
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=50 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=35 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Serum FSH on T+5
|
5.1 mIU/ml
Interval 3.9 to 7.0
|
3.2 mIU/ml
Interval 2.8 to 4.0
|
SECONDARY outcome
Timeframe: 5 daysPopulation: Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population.
Blood samples were collected about 5 days after trigger (T+5) to assess the serum concentration of luteinizing hormone (LH).
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=50 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=35 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Serum LH on T+5
|
0.65 mIU/ml
Interval 0.6 to 1.08
|
0.61 mIU/ml
Interval 0.55 to 0.91
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population.
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).
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=50 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=35 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Follicular hCG
|
11.6 IU/L
Interval 7.0 to 17.5
|
135.3 IU/L
Interval 100.5 to 165.8
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population.
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).
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=50 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=35 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Follicular FSH
|
13.1 mIU/ml
Interval 10.0 to 15.4
|
9.2 mIU/ml
Interval 6.7 to 11.0
|
SECONDARY outcome
Timeframe: 2 daysFollicular 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).
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=50 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=35 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Follicular P4
|
26095 ng/ml
Interval 22445.0 to 38525.0
|
28758 ng/ml
Interval 23015.0 to 37838.0
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population.
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).
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=50 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=35 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Follicular E2
|
842.2 pg/ml
Interval 576.5 to 1321.1
|
672.7 pg/ml
Interval 456.1 to 1021.2
|
SECONDARY outcome
Timeframe: 2 daysPopulation: Only comparisons to the standard 10,000 IU hCG trigger dose are presented using the per-protocol study population.
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).
Outcome measures
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=50 Participants
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=35 Participants
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Follicular VEGF
|
3436 pg/ml
Interval 2289.0 to 4352.0
|
3470 pg/ml
Interval 2596.0 to 4522.0
|
Adverse Events
Low Dose hCG Plus FSH Co-trigger
Standard Dose of hCG Alone
Serious adverse events
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=54 participants at risk
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=51 participants at risk
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Reproductive system and breast disorders
Severe OHSS
|
0.00%
0/54 • 30 days
|
2.0%
1/51 • Number of events 1 • 30 days
|
Other adverse events
| Measure |
Low Dose hCG Plus FSH Co-trigger
n=54 participants at risk
On the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously
|
Standard Dose of hCG Alone
n=51 participants at risk
On the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously.
|
|---|---|---|
|
Reproductive system and breast disorders
Mild OHSS
|
0.00%
0/54 • 30 days
|
2.0%
1/51 • Number of events 1 • 30 days
|
Additional Information
Dr. Yanett Anaya, Assistant Professor
UCSF Center for Reproductive Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place