InfertilityNCT06545877
REKOVELLE PEN for S.C. Injection General Drug Use Survey (Controlled Ovarian Stimulation in Assisted Reproductive Technologies)
An observational study of Infertility, run by Ferring Pharmaceuticals at 1 site in Japan.
Trial summary
This survey targets controlled ovarian stimulation with this drug for the development of multiple oocytes in women undergoing assisted reproduction (ART) such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility
- How many people
- 571 participants
- Where
- 1 siteJapan
- Study dates
- 16 Sep 2022to 28 Feb 2026
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women who are undergoing assisted reproduction (ART) such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
Who may be able to join
- Participants who received the REKOVELLE in controlled ovarian stimulation in assisted reproductive technologies and have consented to participate in the survey.
Who cannot join
- No exclusion criteria because data are collected under conditions of use in daily practice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REKOVELLE® PEN S.C. Injection 12μg/36μg/72μg for Controlled Ovarian Stimulation in Assisted Reproductive Technologies - General Drug Use-results Survey
This survey targets controlled ovarian stimulation with this drug for the development of multiple oocytes in women undergoing assisted reproduction (ART) such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
- Conditions
- Infertility
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Frequency of Adverse Events
Measured: From initiation of the administration, in case of embryo transfer is not performed, until 1 week after oocyte collection, and in case embryo transfer is performed, 6 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 posted9 Aug 2024
- Study start16 Sep 2022
- Primary completion30 Apr 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- 571 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
- NCT06545877
- Sponsor's protocol ID
- 000409
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REKOVELLE® PEN S.C. Injection 12μg/36μg/72μg for Controlled Ovarian Stimulation in Assisted Reproductive Technologies - General Drug Use-results Survey
- ClinicalTrials.gov ID
- NCT06545877
- Acronym / sponsor ID
- 000409
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 571 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 9 Aug 2024 (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 survey targets controlled ovarian stimulation with this drug for the development of multiple oocytes in women undergoing assisted reproduction (ART) such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who are undergoing assisted reproduction (ART) such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
Key inclusion criteria (1 listed)
- Participants who received the REKOVELLE in controlled ovarian stimulation in assisted reproductive technologies and have consented to participate in the survey.
Key exclusion criteria (1 listed)
- No exclusion criteria because data are collected under conditions of use in daily practice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse Events
Time frame: From initiation of the administration, in case of embryo transfer is not performed, until 1 week after oocyte collection, and in case embryo transfer is performed, 6 weeks after embryo transfer
Frequency of Adverse Events
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 3 Sep 2026.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Ferring Pharmaceuticals at 1 site in Japan.
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 1 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 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
Adverse Events (time frame: From initiation of the administration, in case of embryo transfer is not performed, until 1 week after oocyte collection, and in case embryo transfer is performed, 6 weeks after embryo transfer). 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 3 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.