To Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patterns of Use in Real-world Practice

ConditionInfertility
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20+
SponsorFerring Pharmaceuticals

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Live Birth Rate per initiated stimulation cycles

Time frame
Up to 15 months

Secondary outcomes

1

Serum oestradiol levels

Serum oestradiol levels on days of stimulation initiation (before treatment) and at end-of-stimulation

Time frame
Up to 20 days
2

Progesterone (P4) levels

Progesterone (P4) levels on days of stimulation initiation (before treatment) and at end-of-stimulation

Time frame
Up to 20 days
3

Cycle cancellation rate and reasons for cycle cancellation

Time frame
Up to 28 days
4

Number of oocytes retrieved

Time frame
Up to 22 days

Other outcomes

Sponsors and contacts

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