Post Marketing Surveillance of MENOPUR
1 other identifier
observational
2,501
1 country
19
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of highly purified (HP) menotrophine to Korean women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2008
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 3, 2010
CompletedFirst Posted
Study publicly available on registry
September 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFebruary 21, 2014
February 1, 2014
4.9 years
September 3, 2010
February 20, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Number of follicles per cycle
An ART cycle: From ovulation (number and size) to when chemical pregnancy test results are recorded
Up to 6 weeks
Secondary Outcomes (1)
Number of adverse events
Up to 6 weeks
Eligibility Criteria
Infertile women
You may qualify if:
- Anovulation in women (WHO group II)
- Controlled ovarian hyperstimulation cases for ART
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Busan Maria hospital
Busan, Busan, South Korea
Daegu Maria
Daegu, Daegu, South Korea
Daejeon Maria
Daejeon, Daejeon, South Korea
Daejeon Seoul Women Hospital
Daejeon, Daejeon, South Korea
Ellemedi Women Clinic
Daejeon, Daejeon, South Korea
Miz Women's Hospital
Daejeon, Daejeon Metropolitan City, South Korea
Seoul´s Women´s Hospital
Bucheon-si, Gyeonggi Province, South Korea
Ilsan Maria Hospital
Ilsan, Gyeonggi Province, South Korea
Incheon Seoul women Hospital
Incheon, Incheon, South Korea
Premedi Women's Clinic
Kwangju, Kwangju Metropolitan City, South Korea
Gumi CHA University Medical Center
Gumi, Kyoungbuk Province, South Korea
Mama Papa & Baby Hospital
Ulsan, Kyoungnam Province, South Korea
Cheil General Hospital & Women's Healthcare Center
Seoul, Seoul, South Korea
Gangseo Mizmedi Hospital
Seoul, Seoul, South Korea
Hamchoon women clinic
Seoul, Seoul, South Korea
Maria Plus Hospital
Seoul, Seoul, South Korea
Samsung Medical Center
Seoul, Seoul, South Korea
Songnae Maria Hospital
Seoul, Seoul, South Korea
Maria Hospital
Seoul, ´Shinseoul-dong, Dongdaemun-gu, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2010
First Posted
September 15, 2010
Study Start
December 1, 2008
Primary Completion
November 1, 2013
Study Completion
February 1, 2014
Last Updated
February 21, 2014
Record last verified: 2014-02