Overview

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)