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This post-marketing surveillance study was conducted in accordance with the regulations for re-examination of domestic new drugs (Standard for Re-Examination of New Drugs: Ministry of Food and Drug Safety [MFDS]: Notification No. 2017-95, 21 Nov, 2017).
It was important to monitor the pattern of drug use in general practice for a long term after marketing authorization, and to investigate and identify potential new adverse events (AEs) and their onset status that were not observed during the drug development phases and any potential factors that affect safety and effectiveness of the new drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment of Infertility | Non intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Other: Non intervention | Other | Non intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with serious AEs and adverse drug reactions (ADRs) | Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination | |
| Proportion of subjects with unexpected AEs/ADRs not reflected in 'Precautions for Use' | Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination | |
| Proportion of subjects with expected ADRs | Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination | |
| Proportion of subjects with non-serious ADRs | Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination | |
| Proportion of subjects with ovarian hyperstimulation syndrome (OHSS) | Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination | |
| Technical malfunction of REKOVELLE pre-filled pen | Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of the oocytes retrieved | At the oocyte retrieval visit, after completion of controlled ovarian stimulation and approximately 36 hours after human chorionic gonadotropin (hCG) administration. | |
| Ongoing pregnancy rate in women undergoing controlled ovarian stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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Participants receiving REKOVELLE pre-filled pen (follitropin delta) within the range of the approved product labeling in Korea. Participants were enrolled only after the treatment decision had been made and no aspect of this study would interfere with or influence the routine medical procedures and/or medications received.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pyeongchon Maria, 8/9F, Olympic Sports Center120, Dongan-ro, Dongan-gu | Anyang | South Korea | ||||
| Dream-I clinic, 45-17, Huimang-ro 46beon-gil, Baebang-eup |
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| Between 10-11 weeks after embryo transfer |
| Asan |
| South Korea |
| Centum Eroom Woman Clinic, 10F, Centum Tower Medical, 20, Centum-2-ro, Haeundae-gu | Busan | South Korea |
| Eroom women's clinic, 25, Seomyeon-ro, Busanjin-gu | Busan | South Korea |
| Seoul Women's Hospital, 7, Munjeong-ro, Seo-gu | Daejeon | South Korea |
| Creation And Love Women's Hospital, 957, Mujin-daero, Seo-gu | Gwangju | South Korea |
| Mirae and Heemang Women's Hospital, 7F, Dana Medical Center, 68, Jukbong-daero, Seo-gu | Gwangju | South Korea |
| Design Hospital | Jeonju | South Korea |
| Trinium Woman's Hospital, 1834, MainTower, Hannuridae-ro | Sejong | South Korea |
| CHA university Bundang medical center, 59, Yatap-ro, Bundang-gu | Seongnam | South Korea |
| Seoul Nation University Bundang Hospital, 82, Gumi-ro 173beon-gil, Bundang-gu | Seongnam | South Korea |
| M Fertility Center, 12F, 407, Teheran-ro, Gangnam-gu | Seoul | South Korea |
| MariaS (Sangbong), 267, Mangu-ro, Jungnang-gu | Seoul | South Korea |
| Mizmedi Hospital, 295, Gangseo-ro, Gangseo-gu | Seoul | South Korea |
| Seoul Maria Fertility Hospital, 20, Cheonho-daero, Dongdaemun-gu | Seoul | South Korea |
| 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 |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
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