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

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

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 Overview

• Status: Completed
• Conditions: Infertility, Female
• Intervention / Treatment: Other: Other: Non intervention

• Study Type: Observational
• Enrollment (Actual): 728

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Pyeongchon Maria, 8/9F, Olympic Sports Center120, Dongan-ro, Dongan-gu
  • Asan, Korea, Republic of
    • Dream-I clinic, 45-17, Huimang-ro 46beon-gil, Baebang-eup
  • Busan, 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
  • Daejeon, Korea, Republic of
    • Seoul Women's Hospital, 7, Munjeong-ro, Seo-gu
  • Gwangju, 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
  • Jeonju, Korea, Republic of
    • Design Hospital
  • Sejong, Korea, Republic of
    • Trinium Woman's Hospital, 1834, MainTower, Hannuridae-ro
  • Seongnam, Korea, Republic of
    • Seoul Nation University Bundang Hospital, 82, Gumi-ro 173beon-gil, Bundang-gu
  • Seongnam, Korea, Republic of
    • CHA university Bundang medical center, 59, Yatap-ro, Bundang-gu
  • Seoul, 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment of Infertility; Non intervention	Other: Other: Non intervention; Non intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals
• Investigators: Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Actual): October 28, 2023
• Study Completion (Actual): October 28, 2023

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Follitropin Delta; REKOVELLE
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: 000385

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No