Trial Outcomes & Findings for Lutropin Alfa in Women at Risk of Poor Response (NCT NCT01112358)
NCT ID: NCT01112358
Last Updated: 2018-08-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
At the end of stimulation (Day 2 up to Day 8)
Results posted on
2018-08-28
Participant Flow
Participant milestones
| Measure |
r-FSH + r-hLH
Lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
r-FSH
Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
33
|
|
Overall Study
COMPLETED
|
25
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lutropin Alfa in Women at Risk of Poor Response
Baseline characteristics by cohort
| Measure |
r-FSH + r-hLH
n=25 Participants
Lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
r-FSH
n=33 Participants
Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
Total
n=58 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
34.9 Years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
34.4 Years
STANDARD_DEVIATION 2.0 • n=7 Participants
|
34.65 Years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the end of stimulation (Day 2 up to Day 8)Population: ITT population
Outcome measures
| Measure |
r-FSH + r-hLH
n=25 Participants
Lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
r-FSH
n=33 Participants
Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
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|---|---|---|
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Number of Oocytes Retrieved
|
4.0 Oocytes
Standard Deviation 5.3
|
3.5 Oocytes
Standard Deviation 3.1
|
PRIMARY outcome
Timeframe: At the end of stimulation (Day 2 up to Day 8)Population: ITT population
Outcome measures
| Measure |
r-FSH + r-hLH
n=25 Participants
Lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
r-FSH
n=33 Participants
Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
|---|---|---|
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Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter
|
7.2 Follicles
Standard Deviation 1.1
|
7.0 Follicles
Standard Deviation 0.8
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PRIMARY outcome
Timeframe: At the end of stimulation (Day 2 up to Day 8)Population: ITT population
Oocytes recovery rate (oocytes per \>14 mm follicle) is defined as number of oocytes retrieved divided by number of follicles \>14 mm in diameter.
Outcome measures
| Measure |
r-FSH + r-hLH
n=25 Participants
Lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
r-FSH
n=33 Participants
Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
|---|---|---|
|
Oocytes Recovery Rate
|
0.56 oocytes per >14 mm follicle
Standard Deviation 0.42
|
0.50 oocytes per >14 mm follicle
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: At the end of stimulation (Day 2 up to Day 8)Population: ITT population
Oocyte nuclear maturity rate (metaphase II oocytes per retrieved oocyte) is defined as number of metaphase II oocytes divided by total number of oocytes retrieved.
Outcome measures
| Measure |
r-FSH + r-hLH
n=25 Participants
Lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
r-FSH
n=33 Participants
Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
|---|---|---|
|
Oocyte Nuclear Maturity Rate
|
0.73 metaphase II oocytes/retrieved oocyte
Standard Deviation 0.75
|
0.61 metaphase II oocytes/retrieved oocyte
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)Population: ITT population
The fertilization rate (2 pronuclei \[PN\] fertilized oocytes per inseminated oocyte) was defined as number of 2 PN fertilized oocytes divided by number of inseminated oocytes.
Outcome measures
| Measure |
r-FSH + r-hLH
n=25 Participants
Lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
r-FSH
n=33 Participants
Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
|---|---|---|
|
Fertilization Rate
|
0.70 2PN fertilized oocyte/inseminated oocyte
Standard Deviation 0.35
|
0.64 2PN fertilized oocyte/inseminated oocyte
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)Population: ITT population
Embryo quality was graded according to morphological classification of Veeck. Grade 1: even blastomeres with no fragmentation; Grade 2: even blastomeres with slight fragmentation (less than 20%); Grade 3: uneven size blastomeres with no fragmentation; Grade 4: even or uneven size blastomeres with moderate fragmentation (20-25%); and Grade 5: unrecognizable blastomeres with severe fragmentation (\>50%).
Outcome measures
| Measure |
r-FSH + r-hLH
n=25 Participants
Lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
r-FSH
n=33 Participants
Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
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|---|---|---|
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Number of Embryos by Quality
Grade 1
|
0.6 Embroys
Standard Deviation 0.7
|
0.8 Embroys
Standard Deviation 1.0
|
|
Number of Embryos by Quality
Grade 2
|
1.4 Embroys
Standard Deviation 1.8
|
0.7 Embroys
Standard Deviation 0.76
|
|
Number of Embryos by Quality
Grade 3
|
1.8 Embroys
Standard Deviation 2.0
|
0.6 Embroys
Standard Deviation 0.8
|
|
Number of Embryos by Quality
Grade 4
|
0.1 Embroys
Standard Deviation 0.2
|
0.2 Embroys
Standard Deviation 0.3
|
|
Number of Embryos by Quality
Grade 5
|
0.1 Embroys
Standard Deviation 0.2
|
0.0 Embroys
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)Population: ITT population
Outcome measures
| Measure |
r-FSH + r-hLH
n=25 Participants
Lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
r-FSH
n=33 Participants
Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
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|---|---|---|
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Number of Embryos Transferred by In Vitro Fertilization (IVF)
|
2.0 Embroys
Standard Deviation 1.0
|
1.6 Embroys
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)Population: ITT population
The beta Human Chorionic Gonadotropin (beta-hCG) test was used as pregnancy test.
Outcome measures
| Measure |
r-FSH + r-hLH
n=25 Participants
Lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
r-FSH
n=33 Participants
Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
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|---|---|---|
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Number of Participants With Positive Pregnancy Test
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)Population: ITT population
A clinical pregnancy is a pregnancy that is confirmed by both pregnancy test (beta-hCG test) and sonographic confirmation of a gestational sac or heartbeat (fetal sac).
Outcome measures
| Measure |
r-FSH + r-hLH
n=25 Participants
Lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
r-FSH
n=33 Participants
Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
|---|---|---|
|
Number of Participants With Clinical Pregnancy
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)Population: ITT population
Implementation rate (clinical pregnancy/embryo transferred) was defined as the number of clinical pregnancies divided by number of embryos transferred.
Outcome measures
| Measure |
r-FSH + r-hLH
n=25 Participants
Lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
r-FSH
n=33 Participants
Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
|---|---|---|
|
Implementation Rate
|
0.15 Clinical pregnancy/embryo transferred
Interval 0.05 to 0.33
|
0.14 Clinical pregnancy/embryo transferred
Interval 0.05 to 0.28
|
SECONDARY outcome
Timeframe: At the time of r-hCG administration (any days between Day 2 to Day 8)Population: ITT population
Outcome measures
| Measure |
r-FSH + r-hLH
n=25 Participants
Lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
r-FSH
n=33 Participants
Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
|---|---|---|
|
Plasma Level of Estradiol
|
1218 Picograms per milliliters (pg/mL)
Standard Deviation 699
|
1029 Picograms per milliliters (pg/mL)
Standard Deviation 336
|
SECONDARY outcome
Timeframe: At the time of r-hCG administration (any days between Day 2 to Day 8)Population: ITT population
Outcome measures
| Measure |
r-FSH + r-hLH
n=25 Participants
Lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
r-FSH
n=33 Participants
Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
|---|---|---|
|
Endometrial Thickness
|
12.3 millimeters (mm)
Standard Deviation 1.8
|
11.2 millimeters (mm)
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Randomization to Day 8Population: ITT population
Duration of ovarian stimulation was defined as the time from start of study treatment to time of r-hCG administration.
Outcome measures
| Measure |
r-FSH + r-hLH
n=25 Participants
Lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
r-FSH
n=33 Participants
Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
|---|---|---|
|
Duration of Ovarian Stimulation
|
4.8 days
Standard Deviation 1.7
|
4.8 days
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Randomization to Day 8Population: ITT population
Outcome measures
| Measure |
r-FSH + r-hLH
n=25 Participants
Lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
r-FSH
n=33 Participants
Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
|---|---|---|
|
rFSH Cumulative Dose
|
4338 IU
Standard Deviation 1241
|
4298 IU
Standard Deviation 1137
|
SECONDARY outcome
Timeframe: At the time of r-hCG administration (any days between Day 2 to Day 8)Population: ITT population
Outcome measures
| Measure |
r-FSH + r-hLH
n=25 Participants
Lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
r-FSH
n=33 Participants
Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
|---|---|---|
|
Plasma Levels of LH
|
2.8 IU per liter (IU/L)
Standard Deviation 1.0
|
2.1 IU per liter (IU/L)
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Randomization to Day 8Population: ITT population
Outcome measures
| Measure |
r-FSH + r-hLH
n=25 Participants
Lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) was administered at a daily dose of 150 International Units (IU) from the presence of at least one follicle greater than (\>) 14 millimeter (mm) to complete ovarian stimulation. Follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous Gonadotropin Releasing Hormone (GnRH) antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 milligrams (mg) of recombinant Human Chorionic Gonadotropin (r-hCG) was administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
r-FSH
n=33 Participants
Follitropin alfa (r-FSH) was administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose was then adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants also received analogous GnRH antagonist and natural progesterone, as per standard center practice. To complete follicular maturation and trigger ovulation, a single dose of 250 mg of r-hCG was administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist (on Days 2 to 8).
|
|---|---|---|
|
Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled
|
8 Participants
|
8 Participants
|
Adverse Events
r-FSH + r-hLH
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
r-FSH
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
Merck KGaA Communication Center,
Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Phone: 496151725200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place