Anovulation
Conditions
Brief summary
The main purpose of this investigation is to collect information about safety and efficacy of Follistim Injection from actual clinical use to induce ovulation in patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction. 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
For subcutaneous or intramuscular injection, the usual dosage is 50 IU of follitropin beta (recombinant) once daily for 7 days. The dosage should be adjusted subsequently while monitoring the development of follicles (dose increase by 25 IU every 7 days if the response of the ovaries is poor) and, after confirming presence of follicles of 18 mm or larger in mean diameter by the ultrasonic tomography, ovulation is induced by the administration of a human chorionic gonadotropin preparation.
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 |
|---|---|
| Occurrence of ovulation | 3 months, from initiation of treatment to confirmation of pregnancy. |
Secondary
| Measure | Time frame |
|---|---|
| Pregnancy outcome | 3 months, from initiation of treatment to confirmation of pregnancy. |
Outcome results
None listed