DRUG
Post-Marketing Surveillance of the Safety and Efficacy of Orgalutran (Ganirelix)®
Status
Completed
Phase
Not applicable
Enrollment
711
Locations
0
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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).
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Feb 25, 2011
Study start
Feb 2005
Primary completion
Dec 2007
Study completion
Dec 2007
Results posted
Not reported
Registry updated
Apr 3, 2024
Outcomes
What the study measures.
Primary outcomes
Number of retrieved oocytes by COH based on Per stage approach
Time frame · Baseline to End of Study
Number of Serious Adverse Events
Time frame · Baseline to End of Study
Number of Unlabeled (Unexpected) Adverse Drug Reactions
Time frame · Baseline to End of Study
Number of Labeled Adverse Drug Reactions
Time frame · Baseline to End of Study
Number of Non-serious Adverse Events
Time frame · Baseline to End of Study
Number of Adverse events by drug misuse/abuse or drug-drug interaction
Time frame · Baseline to End of Study
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- Not reported
- Maximum age
- Not reported
- Sex
- FEMALE
- Healthy volunteers
- Not reported
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 locations
0 registered sites.
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Ganirelix.
NCT IDStudyPhase / statusEnrollmentUpdated
Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist for Ovarian Stimulation in IVF/ICSI
Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita) · Infertility, Female · Ovulation Induction
Early Phase 1
Not yet recruiting
189
2026-07
Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging in Midlife Women
University of Delaware · Estrogen · Premenopause
Phase 4
Recruiting
30
2026-07
Is the Diurnal Variation in Circulating Levels of Cortisol Reflected in Follicular Fluid of Preovulatory Follicles Close to Ovulation?
ART Fertility Clinics LLC · Healthy
Not applicable
Not yet recruiting
20
2026-05
INTEnsity of ovariaN Stimulation and Embryo Quality
Fundación Santiago Dexeus Font · Infertility
Phase 4
Completed
110
2026-04
Efficacy of Micronized Natural Progesterone vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation.
Instituto Bernabeu · IVF
Phase 4
Completed
150
2026-03
IVF Outcomes With Time-Lapse Culture: Comparison Between PPOS and GnRH Antagonist Protocols
Hanoi Medical University · Infertility (IVF Patients) · Embryo Morphokinetics
Not applicable
Recruiting
148
2026-02
PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study
University Hospital, Ghent · Ovarian Stimulation · Quality of Life
Phase 4
Recruiting
60
2025-12
DPOS Versus GnRH Antagonist Protocol for Oocyte Accumulation in Low Ovarian Reserve Patients: An RCT
Tam Anh TP. Ho Chi Minh General Hospital · Diminished Ovarian Reserve
Not applicable
Recruiting
730
2025-12
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.