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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Treated | Women undergoing controlled ovarian COH for ART |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orgalutran | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Women undergoing COH for ART
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| ID | Term |
|---|---|
| C061018 | ganirelix |
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