Prospective, Multi-centre, Non-Interventional Study to Investigate the Effectiveness of REKOVELLE® for Ovarian Stimulation for Asian Women in Real World Settings
- Registration Number
- NCT06561958
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
Primary objective is to investigate the effectiveness of REKOVELLE® in women undergoing their first REKOVELLE® ovarian stimulation treatment in real world practice in Asian countries.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1500
- Females aged 20 years or older at enrollment
- Serum AMH level >0.5 ng / mL (with the latest result tested within 12 months)
- Who are first time prescribed REKOVELLE for their ovarian stimulation and IVF or ICSI treatment cycle using fresh or frozen ejaculated sperm from male partner or sperm donor (if applicable)
- Willing and able to provide written informed consent
- Have undergone more than 2 COS-IVF / ICSI cycles before the enrollment
- Participating in an interventional clinical trial in which any medication treatment is mandated
- Women with a contraindication for prescription of REKOVELLE treatment
- Oocyte donors
- Undergoing ovarian stimulation for fertility preservation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description REKOVELLE REKOVELLE Participants prescribed REKOVELLE for the first time for controlled ovarian stimulation.
- Primary Outcome Measures
Name Time Method Cumulative live birth rate Up to 12 months Cumulative live birth rate defined as delivery of at least 1 live fetus after 20 completed weeks of gestation, combined fresh and frozen embryo transfers within 12 months after the start of the ovarian stimulation in patients of the first REKOVELLE ovarian stimulation cycle.
- Secondary Outcome Measures
Name Time Method Number of oocytes retrieved Up to 22 days Number of oocytes retrieved at oocyte retrieval
Number of embryos transferred Up to 28 days Embryos transferred in fresh and/or frozen transfer cycles
Frequency and severity of adverse drug reactions (ADRs) and serious adverse events (SAEs) During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer Frequency and severity of ADRs and SAEs as defined by the investigator
Daily Dosage Up to 22 days Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of daily dosage.
Luteal phase support protocol Up to 22 days Treatment pattern will be measured by analysing the luteal phase support protocol.
The Luteinising hormone (LH) surge suppression protocol Up to 22 days Treatment pattern will be measured by analysing the Lutenising hormone (LH) surge suppression protocol.
Implantation rate Up to 28 days Number of gestational sacs, embryos or blastocysts transferred
Multiple pregnancy rate 4 to 5 weeks after transfer More than 1 gestational sac with fetal heart beat 4-5 weeks after transfer
Spontaneous abortion rate Up to 10-11 weeks after transfer Spontaneous abortion is defined as positive hCG test but all intrauterine gestational sacs without fetal heart beat as documented by ultrasound, or there are no viable fetuses observed by ultrasound
Progesterone Hormone levels Up to 20 days Progesterone hormone levels before stimulation and at the end of stimulation day
Transfer cancellation rate and the reason for transfer cancellation Up to 28 days Transfer cancellation rate and the reason for transfer cancellation (no embryo available for transfer, risk of OHSS, endometrium not receptive, high progesterone level, adverse event, any other specified reason for transfer cancellation).
Preventive interventions for ovarian hyperstimulation syndrome (OHSS) During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer. Preventive interventions decided by the investigator (Triggering of final follicular maturation with GnRH agonist and fresh embryo/blastocyst transfer or cryopreservation, Cancellation of fresh embryo/blastocyst transfer)
Number of subjects with mild / moderate / severe ovarian hyperstimulation syndrome (OHSS) During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer Number of subjects with mild / moderate / severe OHSS, defined by the investigator
Trigger Protocol Up to 22 days Treatment pattern will be measured by analysing the trigger protocol.
Number of Metaphase II (MII) oocytes Up to 22 days Number of MII oocytes at oocyte retrieval (only applicable for Intracytoplasmic sperm injection (ICSI))
Number of embryos Day 3 after oocyte retrieval Number of embryos on Day 3 after oocyte retrieved
Number of blastocysts transferred Up to 28 days Blastocysts transferred in fresh and/or frozen transfer cycles
Time to pregnancy 4 to 5 weeks after transfer Time to pregnancy from start date of ovarian stimulation to confirmation of clinical pregnancy
Live birth rate More than 20 weeks after transfer Live birth is defined as delivery of at least 1 live fetus after 20 completed weeks of gestation within 12 months after the start of the ovarian stimulation in patients of the first REKOVELLE ovarian stimulation cycle.
Stimulation Duration Up to 22 days Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of stimulation duration.
Total Dosage Up to 22 days Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of total dosage.
Number of Blastocysts Day 5 after oocyte retrieval Number of Blastocysts on Day 5 after oocyte retrieved
Positive human chorionic gonadotropin (hCG) rate 11 to 15 days after transfer Positive human chorionic gonadotropin (hCG) rate analysed using serum or urine hCG test 11-15 days after transfer
Clinical Pregnancy rate 4 to 5 weeks after transfer Clinical pregnancy rate (at least 1 gestational sac 4-5 weeks after transfer)
Vital Pregnancy 4 to 5 weeks after transfer Vital pregnancy rate (at least 1 intrauterine gestational sac with fetal heartbeat 4-5 weeks after transfer)
Estradiol Hormone levels Up to 20 days Estradiol hormone levels before stimulation and at the end of stimulation day
Ongoing pregnancy rate 9 to 11 weeks after transfer Ongoing pregnancy rate (at least 1 intrauterine viable fetus 9-11 weeks after transfer)
Ectopic pregnancy rate Up to 10-11 weeks after transfer Ectopic pregnancy is defined as extrauterine gestational sac with or without fetal heart beat as documented by ultrasound or surgery.
Cycle cancellation rate and the reason for cycle cancellation Up to 28 days Date when the investigator decides to cancel cycle before oocyte pick up (due to poor ovarian response, excessive ovarian response, any illness which prevents oocyte collection procedure, subject not taking hCG injection at the correct time, subject choice, other) or after oocyte pick-up (due to no oocytes collected, no oocytes fertilized, abnormal fertilization, abnormal embryo development, no embryo development, ovarian hyperstimulation syndrome (OHSS), subject choice, any other specified reason)
Trial Locations
- Locations (1)
Ferring Investigational Site
🇹🇭Bangkok, Thailand