About this trial
This is a multi-centre prospective non-interventional 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.
There will be approximately 2500 patients initiated with REKOVELLE® treatment and enrolled in 30-50 sites in China. The total duration of the study will be approximately 35 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 20 years of age (including the 20th birthday) when signing informed consent
Prescribed REKOVELLE for the first time in controlled ovarian stimulation for in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycles
Willing and able to provide written informed consent
Disqualifiers
Previously undergone more than 1 controlled ovarian stimulation cycles for IVF or ICSI
Currently participating in an interventional clinical study for which treatment with medication is mandated
Currently undergoing ovarian stimulation for fertility preservation or oocytes donation
Contraindications for the use of REKOVELLE
Trial population
Women eligible for enrolment in the study are those scheduled for their first REKOVELLE treatment, with no more than one prior COS cycle for IVF or ICSI, and who meet the inclusion and exclusion criteria. Data from approximately 2,500 patients will be collected.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Live Birth Rate per initiated stimulation cycles
Secondary outcomes
Serum oestradiol levels
Serum oestradiol levels on days of stimulation initiation (before treatment) and at end-of-stimulation
Progesterone (P4) levels
Progesterone (P4) levels on days of stimulation initiation (before treatment) and at end-of-stimulation
Cycle cancellation rate and reasons for cycle cancellation
Number of oocytes retrieved
Sponsors and contacts
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