Trial Outcomes & Findings for The Evaluation of Recombinant LH Supplementation in Patients With Suboptimal Response to Recombinant FSH Undergoing ICSI (NCT NCT02108223)
NCT ID: NCT02108223
Last Updated: 2015-03-20
Results Overview
percentage of participants with a pregnancy (a b-HCG determination was obtained and considered positive if the value was greater than 10 mIU/ml)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
137 participants
Primary outcome timeframe
Up to 9 month
Results posted on
2015-03-20
Participant Flow
Participant milestones
| Measure |
Fix Dose r-FSH (Gonal-f)
The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1
fix dose r-FSH (Gonal-f): recombinant follicle stimulation
|
r-LH Supplementation to r-FSH
On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.
r-LH supplementation: recombinant luteinizing hormone
|
r-FSH (Gonal-f)
Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.
r-FSH (Gonal-f): recombinant follicle stimulation hormone
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
50
|
35
|
|
Overall Study
COMPLETED
|
52
|
50
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Evaluation of Recombinant LH Supplementation in Patients With Suboptimal Response to Recombinant FSH Undergoing ICSI
Baseline characteristics by cohort
| Measure |
Fix Dose r-FSH (Gonal-f)
n=52 Participants
The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1
fix dose r-FSH (Gonal-f): recombinant follicle stimulation
|
r-LH Supplementation to r-FSH
n=50 Participants
On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.
r-LH supplementation: recombinant luteinizing hormone
|
r-FSH (Gonal-f)
n=35 Participants
Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.
r-FSH (Gonal-f): recombinant follicle stimulation hormone
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
137 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
28.7 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
30.3 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
29.4 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
29.5 years
STANDARD_DEVIATION 4.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
137 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Turkey
|
52 participants
n=5 Participants
|
50 participants
n=7 Participants
|
35 participants
n=5 Participants
|
137 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 9 monthPopulation: In Group 1, transfer procedure could not be performed one patient. In Group 2, the cycle was cancelled in two patients. Oocyte could not be obtained in one patient during OPU. In other 2 patients, transfer couldn't be done. In Group 3 transfer procedure could not be performed in one patient. The pregnancy rates per embryo transfer were calculated.
percentage of participants with a pregnancy (a b-HCG determination was obtained and considered positive if the value was greater than 10 mIU/ml)
Outcome measures
| Measure |
Fix Dose r-FSH (Gonal-f) Group 1
n=51 Participants
The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1
fix dose r-FSH (Gonal-f): recombinant follicle stimulation
|
r-LH Supplementation to r-FSH Group 2
n=45 Participants
On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.
r-LH supplementation: recombinant luteinizing hormone
|
r-FSH (Gonal-f) Group 3
n=34 Participants
Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.
r-FSH (Gonal-f): recombinant follicle stimulation hormone
|
|---|---|---|---|
|
Pregnancy Rate
|
64.7 percentage of pregnant participants
|
57.8 percentage of pregnant participants
|
32.4 percentage of pregnant participants
|
SECONDARY outcome
Timeframe: up to 9 monthmedian number of oocytes retrieved per participant
Outcome measures
| Measure |
Fix Dose r-FSH (Gonal-f) Group 1
n=52 Participants
The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1
fix dose r-FSH (Gonal-f): recombinant follicle stimulation
|
r-LH Supplementation to r-FSH Group 2
n=50 Participants
On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.
r-LH supplementation: recombinant luteinizing hormone
|
r-FSH (Gonal-f) Group 3
n=35 Participants
Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.
r-FSH (Gonal-f): recombinant follicle stimulation hormone
|
|---|---|---|---|
|
the Number of Oocytes Retrieved
|
10.8 oocytes
Standard Deviation 4
|
6.6 oocytes
Standard Deviation 3.4
|
6.4 oocytes
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: up to 9 monthmedian number of mature oocytes retrieved per participant
Outcome measures
| Measure |
Fix Dose r-FSH (Gonal-f) Group 1
n=52 Participants
The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1
fix dose r-FSH (Gonal-f): recombinant follicle stimulation
|
r-LH Supplementation to r-FSH Group 2
n=50 Participants
On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.
r-LH supplementation: recombinant luteinizing hormone
|
r-FSH (Gonal-f) Group 3
n=35 Participants
Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.
r-FSH (Gonal-f): recombinant follicle stimulation hormone
|
|---|---|---|---|
|
Number of Mature Oocyte
|
8.9 oocytes
Standard Deviation 3.3
|
5.5 oocytes
Standard Deviation 2.8
|
5.5 oocytes
Standard Deviation 3
|
SECONDARY outcome
Timeframe: up to 9 monthfertilization rate used to measure how many oocytes become fertilized by sperm cells
Outcome measures
| Measure |
Fix Dose r-FSH (Gonal-f) Group 1
n=52 Participants
The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1
fix dose r-FSH (Gonal-f): recombinant follicle stimulation
|
r-LH Supplementation to r-FSH Group 2
n=50 Participants
On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.
r-LH supplementation: recombinant luteinizing hormone
|
r-FSH (Gonal-f) Group 3
n=35 Participants
Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.
r-FSH (Gonal-f): recombinant follicle stimulation hormone
|
|---|---|---|---|
|
Fertilization Rate
|
73.1 percentage of fertilized oocytes
20
|
74.9 percentage of fertilized oocytes
15
|
74.7 percentage of fertilized oocytes
16
|
SECONDARY outcome
Timeframe: up to 9 monthsImplantation rate is the percentage of embryos which successfully undergo implantation
Outcome measures
| Measure |
Fix Dose r-FSH (Gonal-f) Group 1
n=52 Participants
The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1
fix dose r-FSH (Gonal-f): recombinant follicle stimulation
|
r-LH Supplementation to r-FSH Group 2
n=50 Participants
On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.
r-LH supplementation: recombinant luteinizing hormone
|
r-FSH (Gonal-f) Group 3
n=35 Participants
Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.
r-FSH (Gonal-f): recombinant follicle stimulation hormone
|
|---|---|---|---|
|
Implantation Rates
|
34.8 percentage of embryo implantation
15
|
36.1 percentage of embryo implantation
36.1
|
15 percentage of embryo implantation
34.7
|
Adverse Events
Fix Dose r-FSH (Gonal-f)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
r-LH Supplementation to r-FSH
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
r-FSH (Gonal-f)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Fatma yazıcı yılmaz
Sisli etfal training anf research hospital
Phone: +905079234033
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place