Post Marketing Surveillance of MENOPUR

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

Study Overview

• Status: Completed
• Conditions: Infertility

• Study Type: Observational
• Enrollment (Actual): 2501

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Busan Maria hospital
  • Daegu, Korea, Republic of
    • Daegu Maria
  • Daejeon, Korea, Republic of
    • Daejeon Maria
  • Daejeon, Korea, Republic of
    • Daejeon Seoul Women Hospital
  • Daejeon, Korea, Republic of
    • Ellemedi Women Clinic
  • Incheon, Korea, Republic of
    • Incheon Seoul women Hospital
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Cheil General Hospital & Women's Healthcare Center
  • Seoul, Korea, Republic of
    • Gangseo Mizmedi Hospital
  • Seoul, Korea, Republic of
    • Hamchoon women clinic
  • Seoul, Korea, Republic of
    • Maria Plus Hospital
  • Seoul, Korea, Republic of
    • Songnae Maria Hospital
  • Daejeon Metropolitan City
    • Daejeon, Daejeon Metropolitan City, Korea, Republic of
      • Miz Women's Hospital
  • Gyeonggi Province
    • Bucheon, Gyeonggi Province, Korea, Republic of
      • Seoul´s Women´s Hospital
    • Ilsan, Gyeonggi Province, Korea, Republic of
      • Ilsan Maria Hospital
  • Kwangju Metropolitan City
    • Kwangju, Kwangju Metropolitan City, Korea, Republic of
      • Premedi Women's Clinic
  • Kyoungbuk Province
    • Gumi, Kyoungbuk Province, Korea, Republic of
      • Gumi CHA University Medical Center
  • Kyoungnam Province
    • Ulsan, Kyoungnam Province, Korea, Republic of
      • Mama Papa & Baby Hospital
  • ´Shinseoul-dong, Dongdaemun-gu
    • Seoul, ´Shinseoul-dong, Dongdaemun-gu, Korea, Republic of
      • Maria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Infertile women

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: September 3, 2010
• First Submitted That Met QC Criteria: September 14, 2010
• First Posted (ESTIMATE): September 15, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 21, 2014
• Last Update Submitted That Met QC Criteria: February 20, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: FE999906 CS10