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This study was designed to evaluate the ability of gonadotropin releasing hormone (GnRh) agonist to prevent the rise of progesterone during controlled ovarian stimulation for in vitro fertilization (IVF) after the administration of human Chorionic Gonadotropin (hCG) on the first day of menses.
The aim of this study is to evaluate the efficacy of a GnRH agonist in preventing the functional rescue of corpus luteum in women submitted to controlled ovarian stimulation with administration of hCG on the first day of menses and to evaluate its effect on pregnancy rate and ovarian steroidogenesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GnRH agonist | Experimental | 3,6 mg of goserelin acetate (GnRH agonist) will be administered on the 21st day of the menstrual cycle previous to ovarian stimulation. 250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours. |
|
| Control | Active Comparator | 250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRH agonist | Drug | 3,6mg of goserelin acetate, 250mg of hCG, FSH variable dose according to the number of days required for appropriate ovarian stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of functional rescue of corpus luteum | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rate | 6 months | |
| Levels of serum steroids | 6 months | |
| Levels of serum gonadotropins |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cláudia M Gomes, MD | Contact | 551130596122 | cgomes@huntington.com.br | |
| André M Rocha, PhD | Contact | 551130596122 | arocha@huntington.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Paulo Serafini, PhD | Gynecology of Faculty of Medicine of University of SãoPaulo (Disciplina de Ginecologia da Faculdade de Medicina da Universidade de São Paulo) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assisted Reproduction Center "Governor Mário Covas" of the Faculty of Medicine of the University of São Paulo | Recruiting | São Paulo | São Paulo | 05403000 | Brazil |
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| Label | URL |
|---|---|
| University of São Paulo web page | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 4, 2011 | |
| Reset | Sep 7, 2011 |
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|
| Control | Drug | 250mg of hCG, Zoladex, FSH variable dose according to the number of days required for appropriate ovarian stimulation |
|
|
| 6 months |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 4, 2011 | Sep 7, 2011 |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| C412828 | Ovidrel |
| D017273 | Goserelin |
| C571801 | follitropin alfa |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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