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

Infertility Clinical Trial

Official title:

Non-Interventional Clinical Study on Efficacy and Safety of Highly Purified Human Menopausal Gonadotrophin (HP-hMG) Menopur® Multidose in Korean Female Patients With Infertility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835469
• Other study ID #: 000258
• Status: Completed
• Start date: June 2016
• Est. completion date: February 1, 2019

Study information

• Verified date: March 2019
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Menotrophin

Locations

Country	Name	City	State
Korea, Republic of	CL Hospital (there may be other sites in this country)	Gwangju

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate	Defined as presence of at least 1 intrauterine pregnancy with a viable fetus	10-11 weeks after embryo transfer
Secondary	Mean Follicle Stimulating Hormone (FSH) level		At baseline and last stimulation day (max 20 days after start of stimulation)
Secondary	Mean Luteinizing Hormone (LH) level		At baseline and last stimulation day (max 20 days after start of stimulation)
Secondary	Mean Estradiol 2 (E2) level		At baseline and last stimulation day (max 20 days after start of stimulation)
Secondary	Mean endometrial thickness	Measured by transvaginal ultrasound	On last stimulation day (max 20 days after start of stimulation)
Secondary	Follicular development	Number and size of follicles measured by transvaginal ultrasound	On last stimulation day (max 20 days after start of stimulation)
Secondary	Number of oocytes retrieved		36 hours (±2h) after human Chorionic Gonadotrophin (hCG) administration
Secondary	Fertilization rate	Number of oocytes with 2 pronuclei divided by number of metaphase II oocytes	1 day after oocyte retrieval