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| Name | Class |
|---|---|
| Ferring Pharmaceuticals | INDUSTRY |
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The purpose of this study is to determine if utilizing GnRH antagonists versus agonist long protocol during controlled ovarian stimulation (COH) with human-derived gonadotropins for assisted reproduction affects IVF outcome, peak estradiol level, and duration of stimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bravelle & Menopur Agonist Long Protocol | Active Comparator | Patients will use an LH agonist (Lupron) starting on day 18 of the oral contraceptive pill (OCP), 5 units b.i.d. followed by 5 units q.d. beginning on day one of stimulation medications. The 5 units q.d. dose will continue until the day of hCG administration.Patients will administer Bravelle and Menopur for ovarian stimulation. |
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| Bravelle & Menopur Antagonist Protocol | Active Comparator | Patients will complete standard dose of oral contraceptive pill (OCP) and will then administer GnRH antagonist (ganirelix acetate or cetrorelix acetate) 0.25 mg q.d. during the stimulation phase when the lead follicle size reaches 12mm. The antagonist will continue until the day of hCG administration. Patients will administer Bravelle and Menopur for ovarian stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bravelle and Menopur | Drug | Bravelle and Menopur are used for controlled ovarian stimulation (COH) |
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| Measure | Description | Time Frame |
|---|---|---|
| To determine if COH in IVF patients using Bravelle & Menopur with antagonists results in improved or equal IVF results compared to patients using agonist. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| To determined if COH in IVF patients using Bravelle & Menopur with antagonists results in lower peak estradiol levels compared to agonist | One year | |
| To determine if COH patients using Bravelle & Menopur with antagonist antagonists results inn shorter period of stimulation compared with agonist. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Glassner, M.D. | Main Line Fertility Center | Principal Investigator |
| Sharon H. Anderson, Ph.D | Main Line Fertility Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Main Line Fertility Center | Bryn Mawr | Pennsylvania | 19010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Ludwig, Michael. GnRH antagonists. Textbook of Assisted Reproductive Technologies - Laboratory and Clinical Perspectives. Third edition. Edited by Gardner, D, Weissman, A, Howles, C, Shoham, Z. 2009: 539-552. | ||
| 11789740 | Background | Ludwig M, Katalinic A, Diedrich K. Use of GnRH antagonists in ovarian stimulation for assisted reproductive technologies compared to the long protocol. Meta-analysis. Arch Gynecol Obstet. 2001 Nov;265(4):175-82. doi: 10.1007/s00404-001-0267-2. | |
| 11163814 |
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| ID | Term |
|---|---|
| D050477 | Urofollitropin |
| D008596 | Menotropins |
| D016729 | Leuprolide |
| C061018 | ganirelix |
| C062876 | cetrorelix |
| ID | Term |
|---|---|
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Agonist | Drug | Agonist (Lupron) is used to suppress endogenous pituitary LH for the premature LH surges. |
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| Antagonist | Drug | Ganirelix acetate or cetrorelix acetate Agonist is used to suppress endogenous pituitary LH for the premature LH surges. |
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| One year |
| Background |
| Fluker M, Grifo J, Leader A, Levy M, Meldrum D, Muasher SJ, Rinehart J, Rosenwaks Z, Scott RT Jr, Schoolcraft W, Shapiro DB; North American Ganirelix Study Group. Efficacy and safety of ganirelix acetate versus leuprolide acetate in women undergoing controlled ovarian hyperstimulation. Fertil Steril. 2001 Jan;75(1):38-45. doi: 10.1016/s0015-0282(00)01638-1. |
| 10985616 | Background | Ludwig M, Felberbaum RE, Devroey P, Albano C, Riethmuller-Winzen H, Schuler A, Engel W, Diedrich K. Significant reduction of the incidence of ovarian hyperstimulation syndrome (OHSS) by using the LHRH antagonist Cetrorelix (Cetrotide) in controlled ovarian stimulation for assisted reproduction. Arch Gynecol Obstet. 2000 Jul;264(1):29-32. doi: 10.1007/pl00007479. |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D009479 | Neuropeptides |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |