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Difficulties in recruitment
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| Name | Class |
|---|---|
| Programa de Reproducción Asistida F. Puigvert - HSCSP | UNKNOWN |
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Polycystic ovary occurs in 15-20% of the population will be submitted to TRA. Whether it is associated with other signs or symptoms (polycystic ovarian syndrome) as if presented in isolation, its therapeutic management has special connotations sometimes favoring the low response although the standard is the tendency to hyperresponsiveness.
Although there are studies comparing the combination of FSH and LH and FSH in controlled hyperstimulation of these patients, there are no previous prospective randomized studies comparing administration of urinary FSH (hFSH-HP) with a combination of FSH and HCG (HMG HP).
Therefore the aim of this study is to prove that both drugs are comparable in the treatment of these patients. The test substances are marketed in Spain (Fostipur and Meriofert, respectively) with an indication for use in these patients. In this study both medicines will be administered in a randomized way under the usual conditions in which it is used in routine clinical practice to compare the quantity of mature oocytes respect to the total oocytes obtained, as a primary outcome measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fostipur | Active Comparator |
| |
| Meriofert | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hMG-HP | Drug | Ovarian stimulation with hMG-HP (150 IU / day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quantity of mature oocytes respect to the total oocytes | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan J Espinos, MD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundació Puigvert | Barcelona | 08025 | Spain | |||
| Hospital de la Santa Creu i Sant Pau |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D006379 | Helping Behavior |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| hFSH-HP | Drug | Ovarian stimulation with hFSH-HP (150 IU / day) |
|
|
| Barcelona |
| 08026 |
| Spain |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |