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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04654039
Other study ID # 000385
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 26, 2020
Est. completion date October 28, 2023

Study information

Verified date July 2023
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This post-marketing surveillance study is 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 is 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.


Recruitment information / eligibility

Status Completed
Enrollment 728
Est. completion date October 28, 2023
Est. primary completion date October 28, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Patients who were prescribed with REKOVELLE (follitropin delta) for the first time according to the approved administration method and dose - Patients who have consented to personal information use Exclusion Criteria: - Patients who are prohibited from use according to the special warnings and precautions for use of REKOVELLE (follitropin delta)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Other: Non intervention
Non intervention

Locations

Country Name City State
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 CHA Daegu Women's Medical Center Women's 2095, Dalgubeol-daero, Jung-gu Daegu
Korea, Republic of Joymom Infertility Clinic, 359, Jungang-daero, Jung-gu Daegu
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 CHA univerity Bundang medical center, 59, Yatap-ro, Bundang-gu Seongnam
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

Sponsors (1)

Lead Sponsor Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Proportion of subjects with expected ADRs Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination
Primary 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
Primary 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
Primary 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
Secondary 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.
Secondary Ongoing pregnancy rate in women undergoing controlled ovarian stimulation Between 10-11 weeks after embryo transfer
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