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

Organon

Status: Completed

Conditions: Fertilization in Vitro

Treatments: Drug: Follitropin beta

Study type: Observational

Funder types: Industry

Identifiers

NCT00920361

P06130

Details and patient eligibility

About

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.

Enrollment: 1,664 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

1,664 participants in 1 patient group

1

Description:

Patients who underwent IVF

Treatment:

Drug: Follitropin beta