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The main purpose of this investigation is to collect information about safety and efficacy of Follistim Injection from actual clinical use to induce ovulation in patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction (amenorrhea first grade, anovulatory cycle, polycystic ovary syndrome, oligoamenorrhea) who underwent ovulation induction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follitropin beta | Drug | For subcutaneous or intramuscular injection, the usual dosage is 50 IU of follitropin beta (recombinant) once daily for 7 days. The dosage should be adjusted subsequently while monitoring the development of follicles (dose increase by 25 IU every 7 days if the response of the ovaries is poor) and, after confirming presence of follicles of 18 mm or larger in mean diameter by the ultrasonic tomography, ovulation is induced by the administration of a human chorionic gonadotropin preparation. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of ovulation | 3 months, from initiation of treatment to confirmation of pregnancy. |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy outcome | 3 months, from initiation of treatment to confirmation of pregnancy. |
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Inclusion Criteria:
Exclusion Criteria:
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Japanese 300 patients
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| ID | Term |
|---|---|
| D000858 | Anovulation |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C571802 | follitropin beta |
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|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |