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

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.

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Key information

Conditions

Fertilization in Vitro

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follitropin beta

Drug

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.

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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Designated Drug Use Investigation 1 of Follistim Injection

Important dates

Study start: 2005
Primary completion: 2009
Study completion: 2009
First posted: Jun 15, 2009
Registry last updated: Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed