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.
Study Type
OBSERVATIONAL
Enrollment
728
Non intervention
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
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
...and 5 more locations
Proportion of subjects with serious AEs and adverse drug reactions (ADRs)
Time frame: 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'
Time frame: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination
Proportion of subjects with expected ADRs
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination
Number of the oocytes retrieved
Time frame: 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
Time frame: Between 10-11 weeks after embryo transfer
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