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Post Marketing Surveillance of MENOPUR

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ClinicalTrials.gov Identifier: NCT01202123
Recruitment Status : Completed
First Posted : September 15, 2010
Last Update Posted : February 21, 2014
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease
Infertility

Study Design

Study Type : Observational
Actual Enrollment : 2501 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post Marketing Surveillance of MENOPUR
Study Start Date : December 2008
Primary Completion Date : November 2013
Study Completion Date : February 2014
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Number of follicles per cycle [ Time Frame: Up to 6 weeks ]
    An ART cycle: From ovulation (number and size) to when chemical pregnancy test results are recorded


Secondary Outcome Measures :
  1. Number of adverse events [ Time Frame: Up to 6 weeks ]
    An ART cycle: From ovulation (number and size) to when chemical pregnancy test results are recorded


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Infertile women
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202123


Locations
Korea, Republic of
Miz Women's Hospital
Daejeon, Daejeon Metropolitan City, Korea, Republic of
Seoul´s Women´s Hospital
Bucheon, Gyeonggi Province, Korea, Republic of
Ilsan Maria Hospital
Ilsan, Gyeonggi Province, Korea, Republic of
Premedi Women's Clinic
Kwangju, Kwangju Metropolitan City, Korea, Republic of
Gumi CHA University Medical Center
Gumi, Kyoungbuk Province, Korea, Republic of
Mama Papa & Baby Hospital
Ulsan, Kyoungnam Province, Korea, Republic of
Busan Maria hospital
Busan, Korea, Republic of
Daegu Maria
Daegu, Korea, Republic of
Daejeon Maria
Daejeon, Korea, Republic of
Daejeon Seoul Women Hospital
Daejeon, 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
Gangseo Mizmedi Hospital
Seoul, Korea, Republic of
Hamchoon women clinic
Seoul, Korea, Republic of
Maria Plus Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Songnae Maria Hospital
Seoul, Korea, Republic of
Maria Hospital
Seoul, ´Shinseoul-dong, Dongdaemun-gu, Korea, Republic of
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
More Information

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01202123     History of Changes
Other Study ID Numbers: FE999906 CS10
First Posted: September 15, 2010    Key Record Dates
Last Update Posted: February 21, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Menotropins
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs