An Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to In-vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI)

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Follicle Stimulating Hormone

Criteria

Inclusion Criteria:

• Women who are prescribed Gonal-F FbM by their treating physician for their IVF/ICSI treatment cycle will be eligible for this study

Exclusion Criteria:

• 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