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

Fertilization in Vitro Clinical Trial

Official title:

Designated Drug Use Investigation 1 of Follistim Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00920361
• Other study ID #: P06130
• Status: Completed
• Start date: November 2005
• Est. completion date: March 2009

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1664
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fertilization in Vitro

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of retrieved oocytes		2 months, from initiation of treatment to confirmation of pregnancy.
Secondary	Pregnancy outcome		2 months, from initiation of treatment to confirmation of pregnancy.