Fertilization in Vitro
Conditions
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.
Interventions
DRUGFollitropin 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.
Sponsors
Organon and Co
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of retrieved oocytes | 2 months, from initiation of treatment to confirmation of pregnancy. |
Secondary
| Measure | Time frame |
|---|---|
| Pregnancy outcome | 2 months, from initiation of treatment to confirmation of pregnancy. |
Outcome results
None listed