Controlled Ovarian StimulationNORSOSNCT05499052
Trial to Assess the Pattern of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation (IVF) or Intracytoplasmic Sperm Injection (ICSI) Procedures in Routine Clinical Practice
An observational study of Controlled Ovarian Stimulation, run by Ferring Pharmaceuticals at 9 sites in 4 countries.
Trial summary
Study designed to observe the usage patterns, efficacy and safety of REKOVELLE® in women naive to IVF and ICSI, undergoing their first Controlled Ovarian Stimulation (COS) treatment cycle with REKOVELLE® in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Controlled Ovarian Stimulation
- What is being tested?
- REKOVELLE®
- How many people
- 201 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 28 Aug 2022to 14 Mar 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who are prescribed REKOVELLE® undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
Who may be able to join
- Females aged 18 years or older at enrolment
- Who have never been treated with (naïve) in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatment using fresh or frozen ejaculated sperm from male partner or sperm donor
- Who are prescribed REKOVELLE® for the first time, using the dosing algorithm-based on AMH test result and body weight to define the 1st cycle dose regimen with REKOVELLE® according to the approved label
- Who have been informed verbally and in writing about this trial content, signed the inform consent and who do not object to their data being electronically processed
Who cannot join
- Currently participating in an interventional clinical trial in which any treatment or follow-up is mandated
- Women with a contraindication for prescription of REKOVELLE® treatment
- Hypersensitivity to the active substance or to any of the excipients
- Tumours of the hypothalamus or pituitary gland
- Ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
- Gynaecological haemorrhages of unknown aetiology
Show all 14Show fewer
- Ovarian, uterine, or mammary carcinoma
- Primary ovarian failure
- Malformations of sexual organs incompatible with pregnancy
- Fibroid tumours of the uterus incompatible with pregnancy
- Pregnancy and breast feeding
- Women who undergo ovarian stimulation for fertility preservation
- Women placed under judicial protection, guardianship, or supervision
- Women who are considered as vulnerable population
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Denmark5 sites
Ferring Investigational Site
Copenhagen
Ferring Investigational Site
Horsens
Ferring Investigational Site
Køge
Ferring Investigational Site
Odense
Ferring Investigational Site
Søborg
Switzerland2 sites
Ferring Investigational Site
Baden
Ferring Investigational Site
Basel
About this study
Official title: Nordics and Switzerland Prospective Multicentre Non-Interventional Observational Study to Assess the Pattern of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation (IVF) or Intracytoplasmic Sperm Injection (ICSI) Procedures in Routine Clinical Practice (NORSOS)
Study designed to observe the usage patterns, efficacy and safety of REKOVELLE® in women naive to IVF and ICSI, undergoing their first Controlled Ovarian Stimulation (COS) treatment cycle with REKOVELLE® in routine clinical practice.
- Conditions
- Controlled Ovarian Stimulation
- Being tested
- REKOVELLE®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REKOVELLE®Drug
Also called follitropin delta
Subjects must be treated according to the routine clinical practice and REKOVELLE® must be prescribed in accordance with the terms of the marketing authorisation of each participating country.
According to the label the REKOVELLE® dose should be based on a recent determination of body weight and a recent determination of Anti-Müllerian Hormone (AMH) (i.e. within the last 12 months) measured by the following diagnostic tests: ELECSYS AMH Plus immunoassay from Roche or alternatively the ACCESS AMH Advanced from Beckman Coulter or LUMIPULSE G AMH from Fujirebio.
| Study group | Role | What they receive |
|---|---|---|
| REKOVELLE® | Not described Receives: Drug: REKOVELLE® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of the algorithm-based individualized dosing regimen (daily dose of REKOVELLE® administered)
Calculated with body weight and AMH serum level to define the daily dose of REKOVELLE®
Measured: Up to day 1 of REKOVELLE® stimulation
Daily dose of REKOVELLE®
Measured: From day 1 up to day 20 of REKOVELLE® stimulation
Number of days of treatment with REKOVELLE®
Measured: From day 1 up to day 20 of REKOVELLE® stimulation
REKOVELLE® Dose changes
Dose changes is the discretion of the investigator
Measured: From day 1 up to day 20 of REKOVELLE® stimulation
Use of the Algorithm dosing Application
Use of the Ferring developed dosing app for the daily dose calculation by answering yes/no
Measured: Up to day 1 of REKOVELLE® stimulation
Use of GnRH protocol for Lutenizing Hormone surge suppression
Defined as a choice between GnRH agonist and GnRH antagonist
Measured: Up to day 10
Type of drug used for triggering of follicle maturation
Defined as a choice between hCG or GnRH
Measured: Between Day 8 and Day 14
Luteal phase support
Type and the length of luteal phase support is the discretion of the investigator.
Decided as a choice between Progesterone, Oestrogen and hCG
Measured: 24-72 hours after oocyte-retrieval
Secondary outcomes (14)
Rate of ongoing pregnancy (≥1 intrauterine viable fetus 10-11 weeks after embryo transfer) in the fresh cycle
Measured: 10-11 weeks after embryo transfer
Rate of ongoing pregnancy (≥1 intrauterine viable fetus 10-11 weeks after embryo transfer) following the fresh cycle, including also the first frozen embryo transfer
Measured: 10-11 weeks after embryo transfer
Number of oocytes retrieved
Measured: Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) at 34-36 hours
Number of oocytes/embryos/blastocysts frozen
Measured: Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) after oocyte retrieval
Number of embryos/blastocysts transferred
Measured: Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) after oocyte retrieval
Quality of fresh embryos or blastocysts transferred (excellent, good, fair, other)
Measured: Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) after oocyte retrieval
Positive signs of pregnancy (clinical pregnancy)
Clinical pregnancy defined as least one gestational sac.
Measured: Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) Up to 5-6 weeks after embryo transfer
Positive signs of pregnancy (Positive Human chorionic gonadotropin (hCG) test or urine pregnancy test)
Measured: Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) Up to 10-11 weeks after embryo transfer
Pregnancy loss in women with embryo/blastocyst transfer (biochemical pregnancy, spontaneous/elective abortion, ectopic pregnancy, vanishing twin)
Biochemical pregnancy is defined as positive beta hCG (βhCG) test but no gestational sac is observed on later transvaginal ultrasound, or menstruation is reported.
Spontaneous abortion is defined as positive βhCG test but all intrauterine gestational sacs without fetal heart beat as documented by ultrasound, or there are no viable fetuses observed by ultrasound.
Elective abortion is defined as induced abortion done at the request of the woman for other than therapeutic reasons.
Ectopic pregnancy is defined as extrauterine gestational sac with or without fetal heart beat as documented by ultrasound or surgery.
Vanishing twin is defined as spontaneous disappearance of an intrauterine gestational sac with or without heart beat in a pregnancy where one viable fetus remains as documented by ultrasound.
Measured: Up to 10-11 weeks after embryo transfer
Cycle cancellation before or after oocyte pick-up and reason for cycle cancellation
Date when the investigator decides to cancel cycle before oocyte pick up (due to poor ovarian response, excessive ovarian response, any illness which prevents oocyte collection procedure, subject not taking hCG injection at the correct time, subject choice, other) or after oocyte pick-up (due to no oocytes collected, no oocytes fertilized, abnormal fertilization, abnormal embryo development, no embryo development, OHSS, subject choice, other)
Measured: At consultation visit where cycle cancellation decided up to 10-11 weeks after embryo transfer
Adverse drug reactions (ADRs)
Adverse drug reactions (ADRs) defined by the investigator
Measured: During 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after embryo transfer.
Ovarian hyperstimulation syndrome (OHSS) (including mild/moderate/severe)
OHSS defined by the investigator (including mild/moderate/severe)
Measured: During 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after embryo transfer.
Preventive interventions for early OHSS
Preventive interventions decided by the investigator (Triggering of final follicular maturation with GnRH agonist and fresh embryo/blastocyst transfer or cryopreservation, Cancellation of fresh embryo/blastocyst transfer)
Measured: During 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after embryo transfer.
Assessment of overall subject experience and convenience with REKOVELLE® by the Subject Questionnaire (assessed by the subject)
Measured: 34-36 hours after final injection of 1st cycle with REKOVELLE® (average 9 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start28 Aug 2022
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Controlled Ovarian StimulationStudies 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
- 201 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
- NCT05499052
- Sponsor's protocol ID
- 000411
- Acronym
- NORSOS
- Status last verified
- Oct 2025
- First submitted
- 11 Jul 2022
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pinborg A, Sopa N, Ekerhovd E, Iliadis SI, Kaspersen J, Gravotta E, Quaas A. Effectiveness and safety of follitropin delta in routine clinical practice in the Nordics and Switzerland (the NORSOS study): a prospective non-interventional study. Front Endocrinol (Lausanne). 2025 Sep 5;16:1613680. doi: 10.3389/fendo.2025.1613680. eCollection 2025.
PubMed 40979710
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nordics and Switzerland Prospective Multicentre Non-Interventional Observational Study to Assess the Pattern of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation (IVF) or Intracytoplasmic Sperm Injection (ICSI) Procedures in Routine Clinical Practice (NORSOS)
- ClinicalTrials.gov ID
- NCT05499052
- Acronym / sponsor ID
- NORSOS / 000411
- Conditions
- Controlled Ovarian Stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2022 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 12 Aug 2022 (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.
Study designed to observe the usage patterns, efficacy and safety of REKOVELLE® in women naive to IVF and ICSI, undergoing their first Controlled Ovarian Stimulation (COS) treatment cycle with REKOVELLE® in routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REKOVELLE® | – | Drug: REKOVELLE® |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who are prescribed REKOVELLE® undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
Key inclusion criteria (4 listed)
- Females aged 18 years or older at enrolment
- Who have never been treated with (naïve) in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatment using fresh or frozen ejaculated sperm from male partner or sperm donor
- Who are prescribed REKOVELLE® for the first time, using the dosing algorithm-based on AMH test result and body weight to define the 1st cycle dose regimen with REKOVELLE® according to the approved label
- Who have been informed verbally and in writing about this trial content, signed the inform consent and who do not object to their data being electronically processed
Key exclusion criteria (14 listed)
- Currently participating in an interventional clinical trial in which any treatment or follow-up is mandated
- Women with a contraindication for prescription of REKOVELLE® treatment
- Women who undergo ovarian stimulation for fertility preservation
- Women placed under judicial protection, guardianship, or supervision
- Women who are considered as vulnerable population
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 |
|---|---|---|
| REKOVELLE®Also: follitropin deltaSubjects must be treated according to the routine clinical practice and REKOVELLE® must be prescribed in accordance with the terms of the marketing authorisation of each participating country. According to the label the REKOVELLE® dose should be based on a recent determination of body weight and a recent determination of Anti-Müllerian Hormone (AMH) (i.e. within the last 12 months) measured by the following diagnostic tests: ELECSYS AMH Plus immunoassay from Roche or alternatively the ACCESS AMH Advanced from Beckman Coulter or LUMIPULSE G AMH from Fujirebio. | Drug | REKOVELLE® |
Primary outcome
Use of the algorithm-based individualized dosing regimen (daily dose of REKOVELLE® administered)
Time frame: Up to day 1 of REKOVELLE® stimulation
Calculated with body weight and AMH serum level to define the daily dose of REKOVELLE®
Daily dose of REKOVELLE®
Time frame: From day 1 up to day 20 of REKOVELLE® stimulation
Number of days of treatment with REKOVELLE®
Time frame: From day 1 up to day 20 of REKOVELLE® stimulation
REKOVELLE® Dose changes
Time frame: From day 1 up to day 20 of REKOVELLE® stimulation
Dose changes is the discretion of the investigator
Use of the Algorithm dosing Application
Time frame: Up to day 1 of REKOVELLE® stimulation
Use of the Ferring developed dosing app for the daily dose calculation by answering yes/no
Use of GnRH protocol for Lutenizing Hormone surge suppression
Time frame: Up to day 10
Defined as a choice between GnRH agonist and GnRH antagonist
Type of drug used for triggering of follicle maturation
Time frame: Between Day 8 and Day 14
Defined as a choice between hCG or GnRH
Luteal phase support
Time frame: 24-72 hours after oocyte-retrieval
Type and the length of luteal phase support is the discretion of the investigator. Decided as a choice between Progesterone, Oestrogen and hCG
14 secondary outcomes
Rate of ongoing pregnancy (≥1 intrauterine viable fetus 10-11 weeks after embryo transfer) in the fresh cycle
Time frame: 10-11 weeks after embryo transfer
Rate of ongoing pregnancy (≥1 intrauterine viable fetus 10-11 weeks after embryo transfer) following the fresh cycle, including also the first frozen embryo transfer
Time frame: 10-11 weeks after embryo transfer
Number of oocytes retrieved
Time frame: Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) at 34-36 hours
Number of oocytes/embryos/blastocysts frozen
Time frame: Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) after oocyte retrieval
Number of embryos/blastocysts transferred
Time frame: Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) after oocyte retrieval
Quality of fresh embryos or blastocysts transferred (excellent, good, fair, other)
Time frame: Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) after oocyte retrieval
Positive signs of pregnancy (clinical pregnancy)
Time frame: Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) Up to 5-6 weeks after embryo transfer
Positive signs of pregnancy (Positive Human chorionic gonadotropin (hCG) test or urine pregnancy test)
Time frame: Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) Up to 10-11 weeks after embryo transfer
Pregnancy loss in women with embryo/blastocyst transfer (biochemical pregnancy, spontaneous/elective abortion, ectopic pregnancy, vanishing twin)
Time frame: Up to 10-11 weeks after embryo transfer
Cycle cancellation before or after oocyte pick-up and reason for cycle cancellation
Time frame: At consultation visit where cycle cancellation decided up to 10-11 weeks after embryo transfer
Adverse drug reactions (ADRs)
Time frame: During 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after embryo transfer.
Ovarian hyperstimulation syndrome (OHSS) (including mild/moderate/severe)
Time frame: During 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after embryo transfer.
Preventive interventions for early OHSS
Time frame: During 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after embryo transfer.
Assessment of overall subject experience and convenience with REKOVELLE® by the Subject Questionnaire (assessed by the subject)
Time frame: 34-36 hours after final injection of 1st cycle with REKOVELLE® (average 9 days)
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 2 Oct 2025.
- Results publication: PubMed 40979710Pinborg A, Sopa N, Ekerhovd E, Iliadis SI, Kaspersen J, Gravotta E, Quaas A. Effectiveness and safety of follitropin delta in routine clinical practice in the Nordics and Switzerland (the NORSOS study): a prospective non-interventional study. Front Endocrinol (Lausanne). 2025 Sep 5;16:1613680. doi: 10.3389/fendo.2025.1613680. eCollection 2025.
- 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
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Controlled Ovarian Stimulation, run by Ferring Pharmaceuticals at 9 sites in 4 countries.
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 4 inclusion and 14 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 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Denmark, Switzerland, Norway, Sweden. 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?
Use of the algorithm-based individualized dosing regimen (daily dose of REKOVELLE® administered) (time frame: Up to day 1 of REKOVELLE® stimulation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05499052, which also lists 1 linked publication.
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 2 Oct 2025.