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.
Study Type
OBSERVATIONAL
Enrollment
2,500
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGMaanshan Maternal and Child Health Care Hospital
Ma’anshan, Anhui, China
RECRUITINGBeijing Obstetrics And Gynecology Hospital Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGBeijing Chaoyang Hospital (Beijing)
Chaoyang, Beijing Municipality, China
RECRUITINGPeking University First Hospital
Xicheng, Beijing Municipality, China
RECRUITING6th Affiliated Hospital of Sun Yat Sen University
Guangzhou, Guandong, China
RECRUITING3rd Affiliated Hospital of Guangzhou Medical University (Guangzhou)
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
RECRUITINGThe Second Nanning People's Hospital
Nanning, Guangxi, China
RECRUITINGTongji Hospital Tongji Medical College of Hust
Wuhan, Hubei, China
RECRUITING...and 18 more locations
Live Birth Rate per initiated stimulation cycles
Time frame: Up to 15 months
Serum oestradiol levels
Serum oestradiol levels on days of stimulation initiation (before treatment) and at end-of-stimulation
Time frame: Up to 20 days
Progesterone (P4) levels
Progesterone (P4) levels on days of stimulation initiation (before treatment) and at end-of-stimulation
Time frame: Up to 20 days
Cycle cancellation rate and reasons for cycle cancellation
Time frame: Up to 28 days
Number of oocytes retrieved
Time frame: Up to 22 days
Number of metaphase II (MII) oocytes
Number of metaphase II (MII) oocytes for intracytoplasmic sperm injection (ICSI)
Time frame: Up to 22 days
Number of embryos on Day 3 after oocyte retrieval
Time frame: Day 3 after oocyte retrieval
Number of embryos on Day 5 after oocyte retrieval
Time frame: Day 5 after oocyte retrieval
Number of transferred embryos
Time frame: Up to 28 days
Number of transferred blastocysts
Time frame: Up to 28 days
Transfer cancellation rate and reasons for transfer cancellation
Time frame: Up to 28 days
Implantation rate
Number of gestational sacs, embryos or blastocysts transferred
Time frame: Up to 28 days
Positive beta-human chorionic gonadotropin (βhCG) test rate
Time frame: 11-15 days after transfer
Clinical pregnancy rate
At least one intrauterine gestational sac 4-6 weeks after transfer
Time frame: 4 to 6 weeks after transfer
Vital pregnancy rate
At least 1 intrauterine gestational sac with fetal heartbeat 4-6 weeks after transfer
Time frame: 4 to 6 weeks after transfer
Ongoing pregnancy rate
At least 1 intrauterine viable fetus 9-11 weeks after transfer
Time frame: 9 to 11 weeks after transfer
Cumulative ongoing pregnancy rate
Time frame: 9 to 11 days
Time to pregnancy
Time to pregnancy from stimulation initiation to ongoing pregnancy
Time frame: 4 to 6 weeks after transfer
Pregnancy loss rate
Time frame: Up to 10 - 11 weeks after transfer
Live birth rate per initiated stimulation cycles with fresh transfer cycles
Time frame: More than 20 weeks after transfer
Cumulative live birth rate per initiated stimulation cycles
Time frame: More than 20 weeks after transfer
Frequency and severity of adverse drug reactions
Time frame: During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer
Frequency of preventive interventions for early ovarian hyperstimulation syndrome (OHSS)
Time frame: During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer
Frequency of early OHSS
Time frame: Up to 9 days after triggering of final follicular maturation
Frequency of late OHSS
Time frame: Up to 10-11 weeks after transfer
Use of luteinising hormone (LH) surge suppression protocols
Time frame: Up to 22 days
Daily dose of REKOVELLE
Use of REKOVELLE protocol, including daily dose
Time frame: Up to 22 days
Total dose of REKOVELLE
Use of REKOVELLE protocol including total dose
Time frame: Up to 22 days
Stimulation duration
Stimulation duration following use of REKOVELLE protocol
Time frame: Up to 22 days
Use of any other concomitant ovarian stimulation agent, including daily dose, total dose, and stimulation duration
Time frame: Up to 22 days
Use of follicle maturation triggering protocol
Time frame: Up to 22 days
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