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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Busan Maria hospital, Busan, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2013
Study completion: 2014
First posted: Sep 15, 2010
Registry last updated: Feb 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed