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This observational study will examine the safety and efficacy profile of Elonva (corifollitropin alfa) when administered in Korean women undergoing controlled ovarian stimulation (COS) in combination with a gonadotropin-releasing hormone (GnRH) antagonist for the development of multiple follicles in an assisted reproductive technology (ART) program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Enrolled Participants | Women undergoing COS in combination with a GnRH antagonist for the development of multiple follicles in an ART program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| corifollitropin alfa | Drug | 100 or 150 microgram single subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Oocytes Retrieved | At time of oocyte retrieval (up 3 days from human chorionic gonadotropin [hCG] injection) | |
| Number of Participants who Experience Ovarian Hyperstimulation Syndrome (OHSS) | During treatment and up to 30 days after cessation of treatment | |
| Number of Participants who report an serious adverse event (SAE) | During treatment and up to 30 days after cessation of treatment | |
| Number of Participants who report an adverse event (AE) | During treatment and up to 30 days after cessation of treatment |
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Inclusion Criteria:
- Women with an indication for COS prior to in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) who meet the criteria as mentioned in the current Korean ELONVA local label
Exclusion Criteria:
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Women participating in an ART program consisting of COS in combination with a GnRH antagonist in a general clinical setting.
| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C437186 | follicle stimulating hormone, human, with HCG C-terminal peptide |
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| D000091662 | Genital Diseases |
| D007246 | Infertility |