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

Completed

• Conditions: Fertilization in Vitro
• Interventions: Drug: Orgalutran

• Registration Number: NCT01304511
• Lead Sponsor: Organon and Co

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 711

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants Treated	Orgalutran	Women undergoing controlled ovarian COH for ART

Primary Outcome Measures

Name	Time	Method
Number of retrieved oocytes by COH based on Per stage approach	Baseline to End of Study
Number of Serious Adverse Events	Baseline to End of Study
Number of Unlabeled (Unexpected) Adverse Drug Reactions	Baseline to End of Study
Number of Labeled Adverse Drug Reactions	Baseline to End of Study
Number of Non-serious Adverse Events	Baseline to End of Study
Number of Adverse events by drug misuse/abuse or drug-drug interaction	Baseline to End of Study