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Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based on subject baseline characteristics/predictors of ovarian response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gonal-f 112.5 IU | Experimental |
| |
| Gonal-f 37.5 IU | Experimental |
| |
| Gonal-f 75 IU | Experimental |
| |
| Gonal-f 150 IU | Experimental |
| |
| Gonal-f 187.5 IU | Experimental |
| |
| Gonal-f 225 IU | Experimental |
| |
| Gonal-f 262.5 IU | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gonal-f | Drug | GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Oocytes Retrieved | Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects. | Ovum pick up day (34 to 38 hours post r-hCG administration) |
| Measure | Description | Time Frame |
|---|---|---|
| Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH) | As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects. | up to end of stimulation cycle (approximately 31 days) |
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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 |
|---|---|---|---|---|---|---|
| Medical Information | Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19192339 | Background | Olivennes F, Howles CM, Borini A, Germond M, Trew G, Wikland M, Zegers-Hochschild F, Saunders H, Alam V; CONSORT study group. Individualizing FSH dose for assisted reproduction using a novel algorithm: the CONSORT study. Reprod Biomed Online. 2009 Feb;18(2):195-204. doi: 10.1016/s1472-6483(10)60256-8. | |
| 21575853 | Result |
| Label | URL |
|---|---|
| Full FDA approved prescribing information can be found here | View source |
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A total of 166 subjects received at least 1 dose of recombinant human follicle stimulating hormone (r-hFSH). Of these, 161 subjects received r-hFSH in a dose group of 5 or more subjects. As per statistical analysis plan, only dose groups having 5 or more subjects were to be analyzed for efficacy and safety analysis in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gonal-f 37.5 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 37.5 International Units (IU) per day based on assisted reproductive technology (ART) treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter were developed, a single injection of 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) was administered. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Gonal-f 300 IU | Experimental |
|
|
| Recombinant human chorionic gonadotrophin (r-hCG) | Drug | When at least 1 follicle greater than or equal to (>=) 18 millimeter (mm) and 2 follicles >=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered. |
|
| Mean Number of Ovarian Stimulation Days | The mean number of stimulation days were determined based on the treatment administration information collected in the case report form. Ovarian stimulation included time from first r-hFSH injection (stimulation Day) until day on which r-hCG was administered (r-hCG day). As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects. | up to end of stimulation cycle (approximately 31 days) |
| Percentage of Cycles Cancelled Due to Excessive or Inadequate Response to r-hFSH | As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects. | up to end of stimulation cycle (approximately 31 days) |
| Number of Subjects Needing Dose Adjustment | Number of subjects needing increase in dose, decrease in dose or increase and decrease both in dose were reported. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects. | 6 days post r-hFSH treatment |
| Mean Daily Recombinant Human Follicle Stimulating Hormone (r-hFSH) Dose | As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects. | up to end of stimulation cycle (approximately 31 days) |
| 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. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects. | 35-42 days post r-hCG administration |
| Overall Pregnancy Rate, Clinical Rate and Multiple Pregnancy Rate | Overall pregnancy rate was defined as the percentage of subjects with serum beta-hCG levels greater than 10 IU/L. Clinical pregnancy rate was defined as the percentage of subjects with at least 1 ultrasound confirmed gestational sac, with or without foetal heart activity. Multiple pregnancy rate was defined as the percentage of subjects with more than 1 ultrasound confirmed gestational sac in the uterus with fetal heart activity. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects. | 35-42 days post r-hCG administration |
| Olivennes F, Howies CM, Borini A, Germond M, Trew G, Wikland M, Zegers-Hochschild F, Saunders H, Alam V. Individualizing FSH dose for assisted reproduction using a novel algorithm: the CONSORT study. Reprod Biomed Online. 2011 Feb;22 Suppl 1:S73-82. doi: 10.1016/S1472-6483(11)60012-6. |
| FG001 | Gonal-f 75 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| FG002 | Gonal-f 112.5 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| FG003 | Gonal-f 150 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| FG004 | Gonal-f 187.5 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| FG005 | Gonal-f 225 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| FG006 | Gonal-f 262.5 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 262.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| FG007 | Gonal-f 300 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 300 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gonal-f 37.5 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 37.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| BG001 | Gonal-f 75 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| BG002 | Gonal-f 112.5 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| BG003 | Gonal-f 150 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| BG004 | Gonal-f 187.5 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| BG005 | Gonal-f 225 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| BG006 | Gonal-f 262.5 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 262.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| BG007 | Gonal-f 300 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 300 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects. | Intention-To-Treat (ITT) population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects. Here "overall number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Oocytes | Ovum pick up day (34 to 38 hours post r-hCG administration) |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH) | As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects. | ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects. | Posted | Mean | Standard Deviation | International Units (IU) | up to end of stimulation cycle (approximately 31 days) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Number of Ovarian Stimulation Days | The mean number of stimulation days were determined based on the treatment administration information collected in the case report form. Ovarian stimulation included time from first r-hFSH injection (stimulation Day) until day on which r-hCG was administered (r-hCG day). As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects. | ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects. | Posted | Mean | Standard Deviation | Days | up to end of stimulation cycle (approximately 31 days) |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Cycles Cancelled Due to Excessive or Inadequate Response to r-hFSH | As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects. | ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects. | Posted | Number | Percentage of cycles | up to end of stimulation cycle (approximately 31 days) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Needing Dose Adjustment | Number of subjects needing increase in dose, decrease in dose or increase and decrease both in dose were reported. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects. | ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects. | Posted | Number | subjects | 6 days post r-hFSH treatment |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Daily Recombinant Human Follicle Stimulating Hormone (r-hFSH) Dose | As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects. | ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects. | Posted | Mean | Standard Deviation | IU/day | up to end of stimulation cycle (approximately 31 days) |
| |||||||||||||||||||||||||||||||||||||||
| 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. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects. | ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects. Here "overall number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent sacs per embryo | 35-42 days post r-hCG administration |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Pregnancy Rate, Clinical Rate and Multiple Pregnancy Rate | Overall pregnancy rate was defined as the percentage of subjects with serum beta-hCG levels greater than 10 IU/L. Clinical pregnancy rate was defined as the percentage of subjects with at least 1 ultrasound confirmed gestational sac, with or without foetal heart activity. Multiple pregnancy rate was defined as the percentage of subjects with more than 1 ultrasound confirmed gestational sac in the uterus with fetal heart activity. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects. | ITT population included all 161 treated subjects who received at least 1 injection of r-hFSH, and were allocated to a dosage group that contained at least 5 subjects. | Posted | Number | Percentage of subjects | 35-42 days post r-hCG administration |
|
Not provided
As per statistical analysis plan, safety analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gonal-f 75 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 75 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. | 3 | 48 | 11 | 48 | ||
| EG001 | Gonal-f 112.5 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 112.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. | 3 | 45 | 15 | 45 | ||
| EG002 | Gonal-f 150 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. | 1 | 34 | 5 | 34 | ||
| EG003 | Gonal-f 187.5 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. | 1 | 24 | 10 | 24 | ||
| EG004 | Gonal-f 225 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. | 0 | 10 | 3 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Ovarian torsion | Reproductive system and breast disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 6.0 | Non-systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 6.0 | Non-systematic Assessment |
| |
| Imminent abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 6.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Adnexa uteri pain | Reproductive system and breast disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Myasthenic syndrome | Nervous system disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Vulvitis | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Post procedural pain | Injury, poisoning and procedural complications | MedDRA 6.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Uterine operation | Surgical and medical procedures | MedDRA 6.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Ovarian torsion | Reproductive system and breast disorders | MedDRA 6.0 | Non-systematic Assessment |
|
Not provided
| 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 |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571801 | follitropin alfa |
| D015292 | Glycoprotein Hormones, alpha Subunit |
| D006063 | Chorionic Gonadotropin |
| ID | Term |
|---|---|
| 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 |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
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| OG002 | Gonal-f 150 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| OG003 | Gonal-f 187.5 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| OG004 | Gonal-f 225 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
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| OG002 | Gonal-f 150 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| OG003 | Gonal-f 187.5 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| OG004 | Gonal-f 225 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
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| OG002 | Gonal-f 150 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| OG003 | Gonal-f 187.5 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| OG004 | Gonal-f 225 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
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| OG002 | Gonal-f 150 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| OG003 | Gonal-f 187.5 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| OG004 | Gonal-f 225 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
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| OG002 | Gonal-f 150 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| OG003 | Gonal-f 187.5 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| OG004 | Gonal-f 225 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
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| OG002 | Gonal-f 150 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| OG003 | Gonal-f 187.5 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| OG004 | Gonal-f 225 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
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| OG002 | Gonal-f 150 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 150 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| OG003 | Gonal-f 187.5 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 187.5 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
| OG004 | Gonal-f 225 IU | GONAL-f (follitropin alfa) administered subcutaneously, at a dose of 225 IU/day based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. When at least 1 follicle >=18 mm and 2 follicles >=16 mm in diameter were developed, a single injection of 250 mcg of r-hCG was administered. |
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