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

Organon

Status: Completed

Conditions: Fertilization in Vitro

Treatments: Drug: Orgalutran

Study type: Observational

Funder types: Industry

Identifiers

NCT01304511

P08198

Details and patient eligibility

About

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).

Enrollment: 711 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

711 participants in 1 patient group

Participants Treated

Description:

Women undergoing controlled ovarian COH for ART

Treatment:

Drug: Orgalutran