Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)
- Registration Number
- NCT00920361
- Lead Sponsor
- Organon and Co
- Brief Summary
To evaluate dosage and administration method, efficacy and safety of Puregon and the relationship between background factors of patients and dose and administration method.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1664
Inclusion Criteria
- Patients who underwent IVF
Exclusion Criteria
- Patients with tumors of ovary, breast, uterus, pituitary or hypothalamus
- Pregnant or possible pregnant women, or lactating women
- Patients with undiagnosed atypical vaginal bleeding
- Patients with a history of hypersensitivity to any of the ingredients of this product.
- Patients with ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Follitropin beta Patients who underwent IVF
- Primary Outcome Measures
Name Time Method Number of retrieved oocytes 2 months, from initiation of treatment to confirmation of pregnancy.
- Secondary Outcome Measures
Name Time Method Pregnancy outcome 2 months, from initiation of treatment to confirmation of pregnancy.