Infertility, FemaleNCT04654039
Post-Marketing Surveillance (PMS) Protocol of REKOVELLE Pre-Filled Pen (Follitropin Delta)
An observational study of Infertility, Female, run by Ferring Pharmaceuticals at 15 sites in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Other: Non intervention
- How many people
- 728 participants
- Where
- 15 sitesSouth Korea
- Study dates
- 26 Oct 2020to 28 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Participants who are prohibited from use according to the special warnings and precautions for use of REKOVELLE (follitropin delta)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
South Korea15 sites
Pyeongchon Maria, 8/9F, Olympic Sports Center120, Dongan-ro, Dongan-gu
Anyang
Dream-I clinic, 45-17, Huimang-ro 46beon-gil, Baebang-eup
Asan
Centum Eroom Woman Clinic, 10F, Centum Tower Medical, 20, Centum-2-ro, Haeundae-gu
Busan
Eroom women's clinic, 25, Seomyeon-ro, Busanjin-gu
Busan
Seoul Women's Hospital, 7, Munjeong-ro, Seo-gu
Daejeon
Creation And Love Women's Hospital, 957, Mujin-daero, Seo-gu
Gwangju
Mirae and Heemang Women's Hospital, 7F, Dana Medical Center, 68, Jukbong-daero, Seo-gu
Gwangju
Design Hospital
Jeonju
Trinium Woman's Hospital, 1834, MainTower, Hannuridae-ro
Sejong
CHA university Bundang medical center, 59, Yatap-ro, Bundang-gu
Seongnam
Seoul Nation University Bundang Hospital, 82, Gumi-ro 173beon-gil, Bundang-gu
Seongnam
M Fertility Center, 12F, 407, Teheran-ro, Gangnam-gu
Seoul
MariaS (Sangbong), 267, Mangu-ro, Jungnang-gu
Seoul
Mizmedi Hospital, 295, Gangseo-ro, Gangseo-gu
Seoul
Seoul Maria Fertility Hospital, 20, Cheonho-daero, Dongdaemun-gu
Seoul
About this study
Official title: 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.
- Conditions
- Infertility, Female
- Being tested
- Other: Non intervention
- Keywords
- Follitropin Delta, REKOVELLE
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other: Non interventionOther
Non intervention
| Study group | Role | What they receive |
|---|---|---|
| Treatment of Infertility | Non intervention Receives: Other: Other: Non intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with serious AEs and adverse drug reactions (ADRs)
Measured: 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'
Measured: Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination
Proportion of subjects with expected ADRs
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Between 10-11 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start26 Oct 2020
- Primary completion28 Oct 2023
- Study completion28 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 728 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654039
- Sponsor's protocol ID
- 000385
- Status last verified
- Mar 2025
- First submitted
- 16 Nov 2020
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance (PMS) Protocol of REKOVELLE Pre-Filled Pen(Follitropin Delta)
- ClinicalTrials.gov ID
- NCT04654039
- Acronym / sponsor ID
- 000385
- Conditions
- Infertility, Female
- Keywords
- Follitropin Delta, REKOVELLE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 728 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 28 Oct 2023 (actual)
- Study completion
- 28 Oct 2023 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of Infertility | – | Other: Other: Non interventionNon intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Participants who are prohibited from use according to the special warnings and precautions for use of REKOVELLE (follitropin delta)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other: Non interventionNon intervention | Other | Treatment of Infertility |
Primary outcome
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
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
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
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
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
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
2 secondary outcomes
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.
Ongoing pregnancy rate in women undergoing controlled ovarian stimulation
Time frame: Between 10-11 weeks after embryo transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Ferring Pharmaceuticals at 15 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.