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

NCT05499052 | Completed FDA Drug

• 1 other identifier: 000411
• Study Type: observational
• Target: 201
• Locations: 4 countries
• Sites: 9

Brief 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.

Conditions

Controlled Ovarian Stimulation

Outcome Measures

Primary Outcomes (8)

• 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®

  Up to day 1 of REKOVELLE® stimulation

• Daily dose of REKOVELLE®

  From day 1 up to day 20 of REKOVELLE® stimulation

• Number of days of treatment with REKOVELLE®

  From day 1 up to day 20 of REKOVELLE® stimulation

• REKOVELLE® Dose changes

  Dose changes is the discretion of the investigator

  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

  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

  Up to day 10

• Type of drug used for triggering of follicle maturation

  Defined as a choice between hCG or GnRH

  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

  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

  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

  10-11 weeks after embryo transfer

• Number of oocytes retrieved

  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

  Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) after oocyte retrieval

• Number of embryos/blastocysts transferred

  Following 1st cycle with REKOVELLE® (each cycle range is 5-20 days, average 9 days) after oocyte retrieval

Study Arms (1)

REKOVELLE®

Drug: REKOVELLE®

Interventions

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.

Also known as: follitropin delta

REKOVELLE®

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (9)

Ferring Investigational Site

Copenhagen, Denmark

Location

Ferring Investigational Site

Horsens, Denmark

Location

Ferring Investigational Site

Køge, Denmark

Location

Ferring Investigational Site

Odense, Denmark

Location

Ferring Investigational Site

Søborg, Denmark

Location

Ferring Investigational Site

Skien, Norway

Location

Ferring Investigational Site

Malmo, Sweden

Location

Ferring Investigational Site

Baden, Switzerland

Location

Ferring Investigational Site

Basel, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 40979710 BACKGROUND

MeSH Terms

Interventions

follitropin delta

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: August 12, 2022
• Study Start: August 28, 2022
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: October 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); CH (2); DK (5); NO (1)