NCT00920361

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 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,664

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2005

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2009

Completed
Last Updated

February 4, 2022

Status Verified

February 1, 2022

Enrollment Period

3.3 years

First QC Date

June 12, 2009

Last Update Submit

February 2, 2022

Conditions

Fertilization in Vitro

Outcome Measures

Primary Outcomes (1)

  • Number of retrieved oocytes

    2 months, from initiation of treatment to confirmation of pregnancy.

Secondary Outcomes (1)

  • Pregnancy outcome

    2 months, from initiation of treatment to confirmation of pregnancy.

Study Arms (1)

1

Patients who underwent IVF

Drug: Follitropin beta

Interventions

Follitropin betaDRUG

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.

1

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Japanese 1100 patients

You may qualify if:

  • Patients who underwent IVF

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

follitropin beta

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2009

First Posted

June 15, 2009

Study Start

November 1, 2005

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 4, 2022

Record last verified: 2022-02