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

• Status: Completed
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Menotropins

Criteria

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)