Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)
|ClinicalTrials.gov Identifier: NCT00920361|
Recruitment Status : Completed
First Posted : June 15, 2009
Last Update Posted : February 5, 2015
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.
|Condition or disease||Intervention/treatment|
|Fertilization in Vitro||Drug: Follitropin beta|
|Study Type :||Observational|
|Actual Enrollment :||1664 participants|
|Official Title:||Designated Drug Use Investigation 1 of Follistim Injection|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
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.
- Number of retrieved oocytes [ Time Frame: 2 months, from initiation of treatment to confirmation of pregnancy. ]
- Pregnancy outcome [ Time Frame: 2 months, from initiation of treatment to confirmation of pregnancy. ]