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This was a prospective, randomized, Phase II, comparative study with a parallel control for evaluating the efficacy and safety of combined treatment of recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH). The combined treatment was administered at the middle of the follicular phase in subjects undergoing in-vitro fertilisation (IVF) through intracytoplasmic sperm injection (ICSI) and transfer of embryos (ET).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| r-hFSH + r-hLH | Experimental |
| |
| r-hFSH alone | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant human follicle stimulating hormone (r-hFSH) | Drug | Subjects will receive subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Metaphase II (M-II) Oocytes Retrieved | Mean number of M-II oocytes were calculated for subjects undergoing ovum pick up for Intra-cytoplasmic Sperm Injection (ICSI). ICSI is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. Metaphase II stage of the oocyte was classified as the time at which the first polar body was observed microscopically. Metaphase II oocytes are a sub-group of the total number of oocytes. | 36 hours post r-hCG administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Fertilized Oocytes (2 Pronuclei [2PN]) | Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN. |
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Inclusion Criteria:
All subjects must meet the following inclusion criteria within the 6 months prior to starting the pituitary suppression unless otherwise specified:
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 de Cruces, Plaza de Cruces, 12, 48903 | Vizcaya | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20031032 | Result | Matorras R, Prieto B, Exposito A, Mendoza R, Crisol L, Herranz P, Burgues S. Mid-follicular LH supplementation in women aged 35-39 years undergoing ICSI cycles: a randomized controlled study. Reprod Biomed Online. 2009 Dec;19(6):879-87. doi: 10.1016/j.rbmo.2009.09.016. | |
| 21575849 | Result | Matorras R, Prieto B, Exposito A, Mendoza R, Crisol L, Herranz P, Burgues S. Mid-follicular LH supplementation in women aged 35-39 years undergoing ICSI cycles: a randomized controlled study. Reprod Biomed Online. 2011 Feb;22 Suppl 1:S43-51. doi: 10.1016/S1472-6483(11)60008-4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | r-hFSH + r-hLH | Subjects received subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]) along with subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Recombinant human luteinizing hormone (r-hLH) | Drug | Subjects will receive subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. |
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| 36 hours post r-hCG administration |
| Quality of Embryos | Embryos were classified into 5 different grades (1 to 5) based on their capacity of implantation. Grade 1 embryos were those with best capacity of implantation and Grade 5 embryos were those with worst capacity of implantation. Mean number of embryos for each of the 5 grades were reported. | Day 2-3 post r-hCG administration |
| Embryo Implantation Rate | Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100. | 35-42 days post r-hCG administration |
| Clinical Pregnancy Rate | Clinical pregnancy rate defined as the percentage of subjects with a ultrasound confirmation of a gestational sac, with or without fetal heart activity. | 35-42 days post r-hCG administration |
| Mean Number of Follicles Greater Than or Equal to (>=) 14 Millimeter (mm) | Mean number of follicles as per the following categories were presented: >=14 mm and less than (<) 16 mm; >=16 mm and <18 mm and >=18 mm. | r-hCG day (end of stimulation cycle [approximately 28 days]) |
| Endometrial Thickness | r-hCG day (end of stimulation cycle [approximately 28 days]) |
| Number of Cycles Cancelled Due to Unsatisfactory Response | If the subject was not administered with r-hCG and withdrew prematurely from the trail, it is considered as cycle cancellation | r-hCG day (end of stimulation cycle [approximately 28 days]) |
| Mean Number of Oocytes Retrieved | Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocyte from the ovary of the female subject, enabling fertilization outside the body. | 36 hours post r-hCG administration |
| FG001 | r-hFSH Alone | Subjects received subcutaneous injection of a recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | r-hFSH + r-hLH | Subjects received subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]) along with subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG). |
| BG001 | r-hFSH Alone | Subjects received subcutaneous injection of a recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Mean Number of Metaphase II (M-II) Oocytes Retrieved | Mean number of M-II oocytes were calculated for subjects undergoing ovum pick up for Intra-cytoplasmic Sperm Injection (ICSI). ICSI is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. Metaphase II stage of the oocyte was classified as the time at which the first polar body was observed microscopically. Metaphase II oocytes are a sub-group of the total number of oocytes. | The Intention-To-Treat (ITT) analysis set included all the randomized subjects who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | M-II oocytes | 36 hours post r-hCG administration |
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| Secondary | Number of Fertilized Oocytes (2 Pronuclei [2PN]) | Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN. | The ITT analysis set included all the randomized subjects who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | 2PN oocytes | 36 hours post r-hCG administration |
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| Secondary | Quality of Embryos | Embryos were classified into 5 different grades (1 to 5) based on their capacity of implantation. Grade 1 embryos were those with best capacity of implantation and Grade 5 embryos were those with worst capacity of implantation. Mean number of embryos for each of the 5 grades were reported. | The ITT analysis set included all the randomized subjects who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | embryos | Day 2-3 post r-hCG administration |
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| Secondary | Embryo Implantation Rate | Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100. | The ITT analysis set included all the randomized subjects who received at least 1 dose of study medication. | Posted | Number | Percent sacs per embryo | 35-42 days post r-hCG administration |
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| Secondary | Clinical Pregnancy Rate | Clinical pregnancy rate defined as the percentage of subjects with a ultrasound confirmation of a gestational sac, with or without fetal heart activity. | The ITT analysis set included all the randomized subjects who received at least 1 dose of study medication. | Posted | Number | Percentage of subjects | 35-42 days post r-hCG administration |
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| Secondary | Mean Number of Follicles Greater Than or Equal to (>=) 14 Millimeter (mm) | Mean number of follicles as per the following categories were presented: >=14 mm and less than (<) 16 mm; >=16 mm and <18 mm and >=18 mm. | The ITT analysis included all the randomized subjects who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | Follicles | r-hCG day (end of stimulation cycle [approximately 28 days]) |
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| Secondary | Endometrial Thickness | The ITT analysis set included all the randomized subjects who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | mm | r-hCG day (end of stimulation cycle [approximately 28 days]) |
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| Secondary | Number of Cycles Cancelled Due to Unsatisfactory Response | If the subject was not administered with r-hCG and withdrew prematurely from the trail, it is considered as cycle cancellation | The ITT analysis included all the randomized subjects who received at least one dose of study medication. | Posted | Number | cycles | r-hCG day (end of stimulation cycle [approximately 28 days]) |
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| Secondary | Mean Number of Oocytes Retrieved | Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocyte from the ovary of the female subject, enabling fertilization outside the body. | The ITT analysis included all the randomized subjects who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | Oocytes | 36 hours post r-hCG administration |
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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-hFSH + r-hLH | Subjects received subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]) along with subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. Administration of both r-hFSH and r-hLH was suspended 36 hours before administering recombinant human chorionic gonadotrophin (r-hCG). | 0 | 63 | 2 | 63 | ||
| EG001 | r-hFSH Alone | Subjects received subcutaneous injection of a recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]). | 0 | 68 | 0 | 68 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian Hyperstimulation Syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
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| Pelvic Inflammatory Disease | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@merckgroup.com |
| ID | Term |
|---|---|
| D007246 | Infertility |
| D006379 | Helping Behavior |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015292 | Glycoprotein Hormones, alpha Subunit |
| C571801 | follitropin alfa |
| D037101 | Luteinizing Hormone, beta Subunit |
| ID | Term |
|---|---|
| D006063 | Chorionic Gonadotropin |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D005640 | Follicle Stimulating Hormone |
| D006065 | Gonadotropins, Pituitary |
| D007986 | Luteinizing Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D013972 | Thyrotropin |
| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| >=65 years |
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