Post-Marketing Surveillance (PMS) Protocol of REKOVELLE Pre-Filled Pen (Follitropin Delta)
- Conditions
- Infertility, Female
- Registration Number
- NCT04654039
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 728
- Participants who were prescribed with REKOVELLE (follitropin delta) for the first time according to the approved administration method and dose
- Participants who have consented to personal information use
- Participants who are prohibited from use according to the special warnings and precautions for use of REKOVELLE (follitropin delta)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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 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 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
- Secondary Outcome Measures
Name Time Method 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 Between 10-11 weeks after embryo transfer
Trial Locations
- Locations (15)
Design Hospital
🇰🇷Jeonju, Korea, Republic of
CHA university Bundang medical center, 59, Yatap-ro, Bundang-gu
🇰🇷Seongnam, Korea, Republic of
Pyeongchon Maria, 8/9F, Olympic Sports Center120, Dongan-ro, Dongan-gu
🇰🇷Anyang, Korea, Republic of
Dream-I clinic, 45-17, Huimang-ro 46beon-gil, Baebang-eup
🇰🇷Asan, Korea, Republic of
Centum Eroom Woman Clinic, 10F, Centum Tower Medical, 20, Centum-2-ro, Haeundae-gu
🇰🇷Busan, Korea, Republic of
Eroom women's clinic, 25, Seomyeon-ro, Busanjin-gu
🇰🇷Busan, Korea, Republic of
Seoul Women's Hospital, 7, Munjeong-ro, Seo-gu
🇰🇷Daejeon, Korea, Republic of
Creation And Love Women's Hospital, 957, Mujin-daero, Seo-gu
🇰🇷Gwangju, Korea, Republic of
Mirae and Heemang Women's Hospital, 7F, Dana Medical Center, 68, Jukbong-daero, Seo-gu
🇰🇷Gwangju, Korea, Republic of
Trinium Woman's Hospital, 1834, MainTower, Hannuridae-ro
🇰🇷Sejong, Korea, Republic of
Seoul Nation University Bundang Hospital, 82, Gumi-ro 173beon-gil, Bundang-gu
🇰🇷Seongnam, Korea, Republic of
M Fertility Center, 12F, 407, Teheran-ro, Gangnam-gu
🇰🇷Seoul, Korea, Republic of
MariaS (Sangbong), 267, Mangu-ro, Jungnang-gu
🇰🇷Seoul, Korea, Republic of
Mizmedi Hospital, 295, Gangseo-ro, Gangseo-gu
🇰🇷Seoul, Korea, Republic of
Seoul Maria Fertility Hospital, 20, Cheonho-daero, Dongdaemun-gu
🇰🇷Seoul, Korea, Republic of