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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-002229-30 | EudraCT Number |
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Evaluate the effectiveness of adding lutropin alfa (recombinant human luteinizing hormone [r-hLH]) in the middle of the follicular phase compared to no addition, in infertile women at risk of poor response stimulated with follitropin alfa (recombinant Follicle-Stimulating Hormone [r-FSH]) under Gonadotropin Releasing Hormone (GnRH) antagonist in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI), in the number and quality of oocytes, follicular development, fertilization oocyte, embryo quality, and pregnancy rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| r-FSH + r-hLH | Experimental | Lutropin alfa (r-hLH) will be 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 (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive analogous 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) will be administered subcutaneously at 12 hours after the last injection of lutropin alfa and/or follitropin alfa and analogous GnRH antagonist. |
|
| r-FSH | Active Comparator | Follitropin alfa (r-FSH) will be administered at an initial dose of 225-450 IU per day (according to standard center practice); the dose will then be adjusted to ovarian response as assessed by ovarian ultrasound and/or serum estradiol. Participants will also receive 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 will be administered subcutaneously at 12 hours after the last injection of follitropin alfa and analogous GnRH antagonist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| r-FSH | Drug | r-FSH will be administered as specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Oocytes Retrieved | At the end of stimulation (Day 2 up to Day 8) | |
| Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter | At the end of stimulation (Day 2 up to Day 8) | |
| Oocytes Recovery Rate | Oocytes recovery rate (oocytes per >14 mm follicle) is defined as number of oocytes retrieved divided by number of follicles >14 mm in diameter. | At the end of stimulation (Day 2 up to Day 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Oocyte Nuclear Maturity Rate | 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. | At the end of stimulation (Day 2 up to Day 8) |
| Fertilization Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de La Fe | Valencia | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | M.J. Fernández Ramírez, A. Monzó, T. García-Gimeno, J.M. Rubio, V. Montañana, C. Duque, G. Herrero, A. Romeu. Role of LH administration during the follicullar phase in women with risk of low response in ovarian stimulation with FSH and cetrorelix for IVF, REVISTA IBEROAMERICANA DE FERTILIDAD, Vol. 23- nº 5 - Septiembre-Octubre 2006 |
| Label | URL |
|---|---|
| Results publication in spanish language | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent-to-treat (ITT) population included all participants who were randomly assigned to one of two treatment groups and received at least one dose.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Oocytes Retrieved | ITT population | Posted | Mean | Standard Deviation | Oocytes | At the end of stimulation (Day 2 up to Day 8) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center, | Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany | 496151725200 | service@merckgroup.com |
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| ID | Term |
|---|---|
| D006379 | Helping Behavior |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C571801 | follitropin alfa |
| D037101 | Luteinizing Hormone, beta Subunit |
| C062876 | cetrorelix |
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D007986 | Luteinizing Hormone |
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
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| r-hLH | Drug | r-hLH will be administered as specified in the arm description. |
|
|
| Analogous GnRH antagonist | Drug | Analogous GnRH antagonist will be administered as specified in the arm description. |
|
|
| r-hCG | Drug | r-hCG will be administered as specified in the arm description. |
|
| Progesterone | Drug | Progesterone will be administered as specified in the arm description. |
|
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. |
| Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) |
| Number of Embryos by Quality | 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%). | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) |
| Number of Embryos Transferred by In Vitro Fertilization (IVF) | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) |
| Number of Participants With Positive Pregnancy Test | The beta Human Chorionic Gonadotropin (beta-hCG) test was used as pregnancy test. | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) |
| Number of Participants With Clinical Pregnancy | 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). | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) |
| Implementation Rate | Implementation rate (clinical pregnancy/embryo transferred) was defined as the number of clinical pregnancies divided by number of embryos transferred. | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) |
| Plasma Level of Estradiol | At the time of r-hCG administration (any days between Day 2 to Day 8) |
| Endometrial Thickness | At the time of r-hCG administration (any days between Day 2 to Day 8) |
| Duration of Ovarian Stimulation | Duration of ovarian stimulation was defined as the time from start of study treatment to time of r-hCG administration. | Randomization to Day 8 |
| rFSH Cumulative Dose | Randomization to Day 8 |
| Plasma Levels of LH | At the time of r-hCG administration (any days between Day 2 to Day 8) |
| Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled | Randomization to Day 8 |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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). |
|
|
| Primary | Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter | ITT population | Posted | Mean | Standard Deviation | Follicles | At the end of stimulation (Day 2 up to Day 8) |
|
|
|
| Primary | Oocytes Recovery Rate | Oocytes recovery rate (oocytes per >14 mm follicle) is defined as number of oocytes retrieved divided by number of follicles >14 mm in diameter. | ITT population | Posted | Mean | Standard Deviation | oocytes per >14 mm follicle | At the end of stimulation (Day 2 up to Day 8) |
|
|
|
| Secondary | Oocyte Nuclear Maturity Rate | 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. | ITT population | Posted | Mean | Standard Deviation | metaphase II oocytes/retrieved oocyte | At the end of stimulation (Day 2 up to Day 8) |
|
|
|
| Secondary | Fertilization Rate | 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. | ITT population | Posted | Mean | Standard Deviation | 2PN fertilized oocyte/inseminated oocyte | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) |
|
|
|
| Secondary | Number of Embryos by Quality | 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%). | ITT population | Posted | Mean | Standard Deviation | Embroys | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) |
|
|
|
| Secondary | Number of Embryos Transferred by In Vitro Fertilization (IVF) | ITT population | Posted | Mean | Standard Deviation | Embroys | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) |
|
|
|
| Secondary | Number of Participants With Positive Pregnancy Test | The beta Human Chorionic Gonadotropin (beta-hCG) test was used as pregnancy test. | ITT population | Posted | Number | Participants | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) |
|
|
|
| Secondary | Number of Participants With Clinical Pregnancy | 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). | ITT population | Posted | Number | Participants | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) |
|
|
|
| Secondary | Implementation Rate | Implementation rate (clinical pregnancy/embryo transferred) was defined as the number of clinical pregnancies divided by number of embryos transferred. | ITT population | Posted | Number | 95% Confidence Interval | Clinical pregnancy/embryo transferred | Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8) |
|
|
|
| Secondary | Plasma Level of Estradiol | ITT population | Posted | Mean | Standard Deviation | Picograms per milliliters (pg/mL) | At the time of r-hCG administration (any days between Day 2 to Day 8) |
|
|
|
| Secondary | Endometrial Thickness | ITT population | Posted | Mean | Standard Deviation | millimeters (mm) | At the time of r-hCG administration (any days between Day 2 to Day 8) |
|
|
|
| Secondary | Duration of Ovarian Stimulation | Duration of ovarian stimulation was defined as the time from start of study treatment to time of r-hCG administration. | ITT population | Posted | Mean | Standard Deviation | days | Randomization to Day 8 |
|
|
|
| Secondary | rFSH Cumulative Dose | ITT population | Posted | Mean | Standard Deviation | IU | Randomization to Day 8 |
|
|
|
| Secondary | Plasma Levels of LH | ITT population | Posted | Mean | Standard Deviation | IU per liter (IU/L) | At the time of r-hCG administration (any days between Day 2 to Day 8) |
|
|
|
| Secondary | Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled | ITT population | Posted | Number | Participants | Randomization to Day 8 |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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). | 0 | 33 | 0 | 33 |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| Grade 3 |
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| Grade 4 |
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| Grade 5 |
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