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

NCT04654039 | Completed

• 1 other identifier: 000385
• Study Type: observational
• Target: 728
• Locations: 1 country
• Sites: 15

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.

Conditions

Infertility, Female

Keywords

Follitropin Delta; REKOVELLE

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• 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

Study Arms (1)

Treatment of Infertility

Non intervention

Other: Other: Non intervention

Interventions

Other: Non intervention OTHER

Non intervention

Treatment of Infertility

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (15)

Pyeongchon Maria, 8/9F, Olympic Sports Center120, Dongan-ro, Dongan-gu

Anyang, South Korea

Location

Dream-I clinic, 45-17, Huimang-ro 46beon-gil, Baebang-eup

Asan, South Korea

Location

Centum Eroom Woman Clinic, 10F, Centum Tower Medical, 20, Centum-2-ro, Haeundae-gu

Busan, South Korea

Location

Eroom women's clinic, 25, Seomyeon-ro, Busanjin-gu

Busan, South Korea

Location

Seoul Women's Hospital, 7, Munjeong-ro, Seo-gu

Daejeon, South Korea

Location

Creation And Love Women's Hospital, 957, Mujin-daero, Seo-gu

Gwangju, South Korea

Location

Mirae and Heemang Women's Hospital, 7F, Dana Medical Center, 68, Jukbong-daero, Seo-gu

Gwangju, South Korea

Location

Design Hospital

Jeonju, South Korea

Location

Trinium Woman's Hospital, 1834, MainTower, Hannuridae-ro

Sejong, South Korea

Location

CHA university Bundang medical center, 59, Yatap-ro, Bundang-gu

Seongnam, South Korea

Location

Seoul Nation University Bundang Hospital, 82, Gumi-ro 173beon-gil, Bundang-gu

Seongnam, South Korea

Location

M Fertility Center, 12F, 407, Teheran-ro, Gangnam-gu

Seoul, South Korea

Location

MariaS (Sangbong), 267, Mangu-ro, Jungnang-gu

Seoul, South Korea

Location

Mizmedi Hospital, 295, Gangseo-ro, Gangseo-gu

Seoul, South Korea

Location

Seoul Maria Fertility Hospital, 20, Cheonho-daero, Dongdaemun-gu

Seoul, South Korea

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: December 4, 2020
• Study Start: October 26, 2020
• Primary Completion: October 28, 2023
• Study Completion: October 28, 2023
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

KR (15)