Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Designated Drug Use Investigation 1 of Follistim Injection|
- Number of retrieved oocytes [ Time Frame: 2 months, from initiation of treatment to confirmation of pregnancy. ] [ Designated as safety issue: No ]
- Pregnancy outcome [ Time Frame: 2 months, from initiation of treatment to confirmation of pregnancy. ] [ Designated as safety issue: No ]
|Study Start Date:||November 2005|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Patients who underwent IVF
Drug: Follitropin beta
Normally, Follistim Injection 150 or 225 IU will be administered (s.c. or i.m.) once a day for 4 days as follitropin beta (genetical recombination). The dosage will be adapted to growth of follicles (75-375 IU for 6-12 days, in general). If more than 3 follicles of mean diameter 16-20 mm are confirmed by ultrasound tomography, ovulation will be stimulated by using Human Chorionic Gonadotropin (hCG) drugs.