A Study on Efficacy and Safety of Menopur® Multidose in Korean Female Patients With Infertility

Ferring

Status: Completed

Conditions: Infertility

Treatments: Drug: Menotrophin

Study type: Observational

Funder types: Industry

Identifiers

NCT02835469

000258

Details and patient eligibility

About

The purpose of this study is to investigate the ongoing pregnancy rates at 10-11 weeks after embryo transfer in patients treated with Menopur® Multidose

Enrollment: 412 patients

Sex: Female

Ages: 19 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Decision made to prescribe Menopur® multidose according to Summary of product characteristics

• The study cycle will be either

  • 1st controlled ovarian stimulation cycle ever, or
  • 2nd controlled ovarian stimulation cycle ever, or
  • 1st or 2nd controlled ovarian stimulation cycle after having achieved ongoing pregnancy in a previous controlled ovarian stimulation cycle (note: the subject cannot be included if she has had made more than one failed cycle before the cycle resulting in ongoing pregnancy)

Exclusion criteria

• Known ovarian disease (e.g. ovarian cysts, polycystic ovarian disease etc.)

• Diagnosed as "poor responder", defined as either

  • >20 days of gonadotrophin stimulation in a previous controlled ovarian stimulation cycle, or
  • any previous cancellation of a controlled ovarian stimulation cycle due to limited follicular response, or
  • development of less than 4 follicles ≥15 mm in a previous controlled ovarian stimulation cycle

• Ovarian hyperstimulation syndrome (OHSS)

Trial design

412 participants in 1 patient group

Menopur® Multidose

Description:

Treatment according to routine clinical practice.

Treatment:

Drug: Menotrophin