An Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to In-vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI)
A Prospective, Multi-center, Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to IVF/ICSI
1 other identifier
observational
1,539
1 country
1
Brief Summary
This is a prospective, observational study in women using Gonal-F filled-by-mass (FbM) in ovarian hyperstimulation as part of their in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment at infertility clinics in Korea. The purpose of this study is to assess Gonal-F FbM in a practical setting encompassing all subject groups and local practices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2009
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 24, 2010
CompletedFirst Posted
Study publicly available on registry
February 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedJuly 31, 2014
September 1, 2010
11 months
February 24, 2010
July 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy
Number of oocytes retrieved and clinical pregnancy rate per cycle
Start of treatment to confirmation of pregnancy
Secondary Outcomes (1)
Efficacy, Safety and Convenience
Start of treatment to confirmation of pregnancy
Interventions
Follitropin alfa FbM solution for injection in a prefilled pen is available in three strengths: 300 IU/0.5 ml (22 µg/0.5 ml), 450 IU/0.75 ml (33 µg/0.75 ml) and 900 IU/1.5 ml (66 µg/1.5 ml). The starting dose is usually recommended to be between 150 and 300 IU. The dose is then adjusted according to the ovarian response.
Eligibility Criteria
Female subjects who are prescribed Gonal-F FbM by their treating physician for their IVF/ICSI treatment cycle will be eligible for the study.
You may qualify if:
- Women who are prescribed Gonal-F FbM by their treating physician for their IVF/ICSI treatment cycle will be eligible for this study
You may not qualify if:
- Subjects who have hypersensitivity to follitropin alfa, FSH or to any of the excipients
- Subjects with tumors of the hypothalamus and pituitary gland
- Ovarian enlargement or cyst not due to polycystic ovarian disease
- Gynecological hemorrhages of unknown etiology
- Ovarian, uterine or mammary carcinoma
- Primary ovarian failure
- Malformations of sexual organs incompatible with pregnancy
- Fibroid tumors of the uterus incompatible with pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maria Fertility Hospital
Seoul, South Korea
Biospecimen
Serum samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 24, 2010
First Posted
February 25, 2010
Study Start
April 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
July 31, 2014
Record last verified: 2010-09