Conditions: Infertility, Female
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 112
Healthy volunteers: no

Brief summary:
The objective of this study was to demonstrate the non-inferiority of IVFM HP Inj. by evaluating its efficacy versus Menopur® Inj. in infertility women undergoing the in vitro fertilization and embryo transfer (IVF-ET) among the assisted reproductive technologies.

Detailed description:

Arms:
arm 1: administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.

Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). arm 2: administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.

Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).

Interventions: intervention 1: IVF-M HP Inj. intervention 2: Menopur® Inj.
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: