Post Marketing Surveillance of MENOPUR

Completed

• Conditions: Infertility

• Registration Number: NCT01202123
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of highly purified (HP) menotrophine to Korean women.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-15
• Primary Completion: 2013-11
• Status Verified: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-20
• Last Update Posted: 2014-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2501

Inclusion Criteria

• Anovulation in women (WHO group II)
• Controlled ovarian hyperstimulation cases for ART

Exclusion Criteria

• Hypersensitivity to MENOPUR
• Pregnancy, lactation or contraindication to pregnancy
• Ovarian cysts not related to polycystic ovarian syndrome
• Abnormal uterine bleeding
• Tumors in uterus, ovaries and breasts
• Ovarian hyperstimulation syndrome
• Thromboembolism or history of it
• Infertile due to other reason than anovulation
• High FSH level indication primary ovarian failure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of follicles per cycle	Up to 6 weeks	An ART cycle: From ovulation (number and size) to when chemical pregnancy test results are recorded

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	Up to 6 weeks	An ART cycle: From ovulation (number and size) to when chemical pregnancy test results are recorded

Trial Locations

Locations (19)

Daejeon Maria; 🇰🇷 Daejeon, Korea, Republic of

Ilsan Maria Hospital; 🇰🇷 Ilsan, Gyeonggi Province, Korea, Republic of

Songnae Maria Hospital; 🇰🇷 Seoul, Korea, Republic of

Daejeon Seoul Women Hospital; 🇰🇷 Daejeon, Korea, Republic of

Gangseo Mizmedi Hospital; 🇰🇷 Seoul, Korea, Republic of

Mama Papa & Baby Hospital; 🇰🇷 Ulsan, Kyoungnam Province, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Maria Hospital; 🇰🇷 Seoul, ´Shinseoul-dong, Dongdaemun-gu, Korea, Republic of

Miz Women's Hospital; 🇰🇷 Daejeon, Daejeon Metropolitan City, Korea, Republic of

Premedi Women's Clinic; 🇰🇷 Kwangju, Kwangju Metropolitan City, Korea, Republic of

Seoul´s Women´s Hospital; 🇰🇷 Bucheon, Gyeonggi Province, Korea, Republic of

Gumi CHA University Medical Center; 🇰🇷 Gumi, Kyoungbuk Province, Korea, Republic of

Busan Maria hospital; 🇰🇷 Busan, Korea, Republic of

Daegu Maria; 🇰🇷 Daegu, Korea, Republic of

Ellemedi Women Clinic; 🇰🇷 Daejeon, Korea, Republic of

Incheon Seoul women Hospital; 🇰🇷 Incheon, Korea, Republic of

Cheil General Hospital & Women's Healthcare Center; 🇰🇷 Seoul, Korea, Republic of

Maria Plus Hospital; 🇰🇷 Seoul, Korea, Republic of

Hamchoon women clinic; 🇰🇷 Seoul, Korea, Republic of