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

Designated Drug Use Investigation 1 of Follistim Injection

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 Overview

• Status: Completed
• Conditions: Fertilization in Vitro
• Intervention / Treatment: Drug: Follitropin beta

• Study Type: Observational
• Enrollment (Actual): 1664

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Japanese 1100 patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

1; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of retrieved oocytes	2 months, from initiation of treatment to confirmation of pregnancy.

Secondary Outcome Measures

Outcome Measure	Time Frame
Pregnancy outcome	2 months, from initiation of treatment to confirmation of pregnancy.

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: June 12, 2009
• First Submitted That Met QC Criteria: June 12, 2009
• First Posted (Estimate): June 15, 2009

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone
• Other Study ID Numbers: P06130