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Completed

NCT Number: NCT04654039

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Other: Non intervention

Other

Non intervention

Primary outcomes

  1. Proportion of subjects with serious AEs and adverse drug reactions (ADRs)

    Time frame: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination

  2. Proportion of subjects with unexpected AEs/ADRs not reflected in 'Precautions for Use'

    Time frame: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination

  3. Proportion of subjects with expected ADRs

    Time frame: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination

  4. Proportion of subjects with non-serious ADRs

    Time frame: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination

  5. Proportion of subjects with ovarian hyperstimulation syndrome (OHSS)

    Time frame: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination

  6. Technical malfunction of REKOVELLE pre-filled pen

    Time frame: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination

Secondary outcomes

  1. Number of the oocytes retrieved

    Time frame: At the oocyte retrieval visit, after completion of controlled ovarian stimulation and approximately 36 hours after human chorionic gonadotropin (hCG) administration.

  2. Ongoing pregnancy rate in women undergoing controlled ovarian stimulation

    Time frame: Between 10-11 weeks after embryo transfer

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 4, 2020
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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