Post-Marketing Surveillance (PMS) Protocol of REKOVELLE Pre-Filled Pen (Follitropin Delta)

Infertility, Female Clinical Trial

Official title:

Post-Marketing Surveillance (PMS) Protocol of REKOVELLE Pre-Filled Pen(Follitropin Delta)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04654039
• Other study ID #: 000385
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

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