Clinical trial NCT04654039: Post-Marketing Surveillance (PMS) Protocol of REKOVELLE Pre-Filled Pen (Follitropin Delta)
Official title: Post-Marketing Surveillance (PMS) Protocol of REKOVELLE Pre-Filled Pen(Follitropin Delta)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
Keywords: Follitropin Delta
REKOVELLE
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-12-04
Enrollment: 728
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Participants who are prohibited from use according to the special warnings and precautions for use of REKOVELLE (follitropin delta)

Primary outcomes:
measure: Proportion of subjects with serious AEs and adverse drug reactions (ADRs)
timeFrame: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination
measure: Proportion of subjects with unexpected AEs/ADRs not reflected in 'Precautions for Use'
timeFrame: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination
measure: Proportion of subjects with expected ADRs
timeFrame: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination
measure: Proportion of subjects with non-serious ADRs
timeFrame: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination
measure: Proportion of subjects with ovarian hyperstimulation syndrome (OHSS)
timeFrame: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination
measure: Technical malfunction of REKOVELLE pre-filled pen
timeFrame: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination
Secondary outcomes:
measure: Number of the oocytes retrieved
timeFrame: At the oocyte retrieval visit, after completion of controlled ovarian stimulation and approximately 36 hours after human chorionic gonadotropin (hCG) administration.
measure: Ongoing pregnancy rate in women undergoing controlled ovarian stimulation
timeFrame: Between 10-11 weeks after embryo transfer
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Pyeongchon Maria, 8/9F, Olympic Sports Center120, Dongan-ro, Dongan-gu
city: Asan
country: Korea, Republic of
facility: Dream-I clinic, 45-17, Huimang-ro 46beon-gil, Baebang-eup
city: Busan
country: Korea, Republic of
facility: Centum Eroom Woman Clinic, 10F, Centum Tower Medical, 20, Centum-2-ro, Haeundae-gu
city: Busan
country: Korea, Republic of
facility: Eroom women's clinic, 25, Seomyeon-ro, Busanjin-gu
city: Daejeon
country: Korea, Republic of
facility: Seoul Women's Hospital, 7, Munjeong-ro, Seo-gu
city: Gwangju
country: Korea, Republic of
facility: Creation And Love Women's Hospital, 957, Mujin-daero, Seo-gu
city: Gwangju
country: Korea, Republic of
facility: Mirae and Heemang Women's Hospital, 7F, Dana Medical Center, 68, Jukbong-daero, Seo-gu
city: Jeonju
country: Korea, Republic of
facility: Design Hospital
city: Sejong
country: Korea, Republic of
facility: Trinium Woman's Hospital, 1834, MainTower, Hannuridae-ro
city: Seongnam
country: Korea, Republic of
facility: CHA university Bundang medical center, 59, Yatap-ro, Bundang-gu
city: Seongnam
country: Korea, Republic of
facility: Seoul Nation University Bundang Hospital, 82, Gumi-ro 173beon-gil, Bundang-gu
city: Seoul
country: Korea, Republic of
facility: M Fertility Center, 12F, 407, Teheran-ro, Gangnam-gu
city: Seoul
country: Korea, Republic of
facility: MariaS (Sangbong), 267, Mangu-ro, Jungnang-gu
city: Seoul
country: Korea, Republic of
facility: Mizmedi Hospital, 295, Gangseo-ro, Gangseo-gu
city: Seoul
country: Korea, Republic of
facility: Seoul Maria Fertility Hospital, 20, Cheonho-daero, Dongdaemun-gu
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: