Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)

N/ACompletedNCT00920361

Organon and Co1,664 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,664

Conditions

Fertilization in Vitro

Interventions

Follitropin betaDRUG

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.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of retrieved oocytes

Time frame: 2 months, from initiation of treatment to confirmation of pregnancy.

Secondary Outcomes

Pregnancy outcome

Time frame: 2 months, from initiation of treatment to confirmation of pregnancy.

Data from ClinicalTrials.gov

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