Status:

COMPLETED

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

Lead Sponsor:

Organon and Co

Conditions:

Fertilization in Vitro

Eligibility:

FEMALE

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...

Eligibility Criteria

Inclusion

  • Patients who underwent IVF

Exclusion

  • 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

Key Trial Info

Start Date :

November 1 2005

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 1 2009

Estimated Enrollment :

1664 Patients enrolled

Trial Details

Trial ID

NCT00920361

Start Date

November 1 2005

End Date

March 1 2009

Last Update

February 4 2022

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