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OpenTrials
Completed

NCT Number: NCT01304511

Post-Marketing Surveillance of the Safety and Efficacy of Orgalutran (Ganirelix)®

The purpose of this post-marketing surveillance is to identify problems and questions regarding the safety and efficacy of Orgalutran (Ganirelix)® when used for the prevention of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).

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Key information

Conditions

Fertilization in Vitro

Sex eligibility

Female

Study type

Observational

Who can participate

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

Inclusion criteria

  • Must be undergoing COH for ART

Exclusion criteria

  • Hypersensitivity to the active substance or to any of the excipients
  • Hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH analogue
  • Moderate or severe impairment of renal or hepatic function
  • Pregnancy or lactation

Treatment and study plan

Orgalutran

Drug

Other names: Ganirelix®

Primary outcomes

  1. Number of retrieved oocytes by COH based on Per stage approach

    Time frame: Baseline to End of Study

  2. Number of Serious Adverse Events

    Time frame: Baseline to End of Study

  3. Number of Unlabeled (Unexpected) Adverse Drug Reactions

    Time frame: Baseline to End of Study

  4. Number of Labeled Adverse Drug Reactions

    Time frame: Baseline to End of Study

  5. Number of Non-serious Adverse Events

    Time frame: Baseline to End of Study

  6. Number of Adverse events by drug misuse/abuse or drug-drug interaction

    Time frame: Baseline to End of Study

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Post-Marketing Surveillance Orgalutran (Ganirelix)®

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Feb 25, 2011
Registry last updated
Apr 3, 2024

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.

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