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To demonstrate the comparative safety and efficacy of Cetrotide® 3 milligram (mg) and Antagon™ in the inhibition of a premature luteinizing hormone (LH) surge in women undergoing ovarian stimulation with recombinant human follicle stimulating hormone/human menopausal gonadotropin (r-hFSH/hMG) prior to assisted reproductive technology (ART) and utilizing oral contraceptives pill (OCP) for cycle programming.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetrotide® | Experimental |
| |
| Antagon ™ | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetrotide® | Drug | Cetrotide® will be administered subcutaneously as 3 mg injection when the lead follicle is >=14 mm till r-hCG day. If the subject did not achieve follicular maturation and did not receive r-hCG within 4 days, then the Cetrotide® will be administered at dose of 0.25 mg subcutaneously on successive days until r-hCG day. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects without premature luteinizing hormone (LH) surge | r-hCG administration day (end of stimulation cycle {approximately 4 days}) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of study treatment | Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle {approximately 4 days}) | |
| Total dose of recombinant human follicle stimulating hormone/human menopausal gonadotropin (r-hFSH/hMG) administered |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Kelly, MD, MBA | EMD Serono | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16009165 | Background | Wilcox J, Potter D, Moore M, Ferrande L, Kelly E; CAP IV Investigator Group. Prospective, randomized trial comparing cetrorelix acetate and ganirelix acetate in a programmed, flexible protocol for premature luteinizing hormone surge prevention in assisted reproductive technologies. Fertil Steril. 2005 Jul;84(1):108-17. doi: 10.1016/j.fertnstert.2005.03.016. |
| Label | URL |
|---|---|
| Study published in Fertility \& Sterility 84(1):108-17;2005 | View source |
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| Antagon ™ | Drug | Antagon™ will be administered subcutaneously at a dose of 0.25 mg once daily when the lead follicle is >=14 mm until r-hCG day. |
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| Recombinant human follicle stimulating hormone (r-hFSH) | Drug | Recombinant human follicle stimulating hormone (r-hFSH) will be administered at a starting dose of 225 international unit (IU) subcutaneously once daily from S1 up to Stimulation Day 5 (S5). Beginning on Stimulation Day 6 (S6), the r-hFSH dose will be individualized to the subject. The minimum and maximum daily doses are 75 IU and 450 IU, respectively until r-hCG day. |
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| Human Menopausal Gonadotropin (hMG) | Drug | Human menopausal gonadotropin (hMG) will be administered subcutaneously daily at a dose of 75 IU till r-hCG day. The total daily dose of r-hFSH and hMG combined is not to exceed 450 IU (375 IU r-hFSH and 75 IU hMG). |
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| Recombinant Human Choriogonadotropin (r-hCG) | Drug | The r-hCG will be administered as a single dose of 250 microgram (mcg) subcutaneously when there is at least one follicle of >=18 mm and two additional follicles of >=16 mm with an appropriate plasma estradiol levels for the number and size of the existing follicles. The r-hCG will be administered within 36 hours after the last dose of the r-hFSH/hMG. |
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| Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle {approximately 4 days}) |
| Duration of gonadotropin therapy | Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle {approximately 4 days}) |
| Number of follicles greater than or equal to (>=) 14 millimeter (mm) on day of recombinant human chorionic gonadotropin (r-hCG) administration | r-hCG administration day (end of stimulation cycle {approximately 4 days}) |
| Number of oocytes retrieved | Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}]) |
| Number of mature oocytes retrieved | OPU day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}]) |
| Number of fertilized oocytes | Day 1 post OPU day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}]) |
| Number and Quality of Embryos | Day 2-3 post OPU (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}]) |
| Implantation rate | Day 35-42 post r-hCG administration day (end of stimulation cycle {approximately 4 days}) |
| Total number of transferred and cryopreserved embryos | Day 2-3 post OPU (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}]) |
| Percentage of subjects with clinical and biochemical pregnancies | Day 35-42 post r-hCG administration day (end of stimulation cycle {approximately 4 days}) |
| Quality of Life assessed by Short Form- 36 (SF-36) Questionnaire | Stimulation Day 1 (S1) and Day 15-18 post r-hCG administration (end of stimulation cycle {approximately 4 days}) |
| Full FDA approved prescribing information can be found here | View source |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C062876 | cetrorelix |
| C061018 | ganirelix |
| D015292 | Glycoprotein Hormones, alpha Subunit |
| C571801 | follitropin alfa |
| D008596 | Menotropins |
| C412828 | Ovidrel |
| 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 |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |
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