PROFILE - NIS to Assess the Patterns of Use of REKOVELLE
Research type
Research Study
Full title
Prospective Multicentre non-Interventional Study to Assess the Patterns of Use of REKOVELLE in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures in Routine Clinical Practice
IRAS ID
236413
Contact name
Nicholas Macklon
Contact email
Sponsor organisation
Ferring International Center SA
Duration of Study in the UK
2 years, 5 months, 29 days
Research summary
This is an international, multi-centre, prospective, post-authorisation, non-interventional cohort study conducted in normal care settings in fertility clinics that will collect information from women naïve undergoing in-vitro fertilisation or intracytoplasmic sperm injection and treated with REKOVELLE undergoing up to a maximum of 3 treatment cycles.
Baseline and follow-up assessments will be performed by the investigators during routine local clinical care visits and are thereby naturalistic in nature.
The patients enrolled in the study will be asked to complete 5 kind of questionnaires along the study based on the fertility quality of life tool (FertiQoL): Baseline persistence questionnaire, Environmental questionnaire, Tolerability questionnaire, Follow-up persistence questionnaire, Patient drop-out questionnaire. Questionnaires will be completed via a digital platform.
Only patients undergoing in-vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) for the first time (i.e. naïve to those procedures) will be enrolled in this study. Based on the observational nature of the study, all the assessments, tests or exams will be done as part of routine clinical practice: no assessments, tests or exams will be done specifically for the study and therefore collected only if available. These assessments, tests or exams are thereby naturalistic in nature as they are completely done at the discretion of the site, based on routine care visits and not following any study specific requirement. In case such assessments, tests or exams are available (as per routine care), they will be extracted from the patients’ clinical records and tracked in the eCRF for the study purpose, only upon the signed Informed Consent given by the patient at the time of the enrolment.REC name
London - Surrey Research Ethics Committee
REC reference
18/LO/0338
Date of REC Opinion
30 Mar 2018
REC opinion
Further Information Favourable Opinion