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Completed

NCT Number: NCT05499052

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

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.

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Key information

Conditions

Controlled Ovarian Stimulation

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Ferring Investigational Site, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

REKOVELLE®

Drug

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.

Other names: follitropin delta

Primary outcomes

  1. 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®

  2. Daily dose of REKOVELLE®

    Time frame: From day 1 up to day 20 of REKOVELLE® stimulation

  3. Number of days of treatment with REKOVELLE®

    Time frame: From day 1 up to day 20 of REKOVELLE® stimulation

  4. REKOVELLE® Dose changes

    Time frame: From day 1 up to day 20 of REKOVELLE® stimulation

    Dose changes is the discretion of the investigator

  5. 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

  6. 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

  7. 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

  8. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

    Clinical pregnancy defined as least one gestational sac.

  8. 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

  9. 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

    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.

  10. 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

    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)

  11. 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.

    Adverse drug reactions (ADRs) defined by the investigator

  12. 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.

    OHSS defined by the investigator (including mild/moderate/severe)

  13. 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.

    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)

  14. 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)

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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)

Acronym: NORSOS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2022
Registry last updated
Oct 2, 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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