Prospective, Multi-centre, Non-Interventional Study to Investigate the Effectiveness of REKOVELLE® for Ovarian Stimulation for Asian Women in Real World Settings
NCT Number: NCT06561958
Acronym: PROFOUND
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Infertility
Interventions: DRUG: REKOVELLE
Sponsor: Ferring Pharmaceuticals
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 1500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-31
Completion Date: 2027-08-01

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.

Primary Outcome Measures: Cumulative live birth rate, 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., Up to 12 months
Secondary Outcome Measures: The Luteinising hormone (LH) surge suppression protocol, Treatment pattern will be measured by analysing the Lutenising hormone (LH) surge suppression protocol., Up to 22 days|Daily Dosage, Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of daily dosage., Up to 22 days|Stimulation Duration, Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of stimulation duration., Up to 22 days|Total Dosage, Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of total dosage., Up to 22 days|Trigger Protocol, Treatment pattern will be measured by analysing the trigger protocol., Up to 22 days|Luteal phase support protocol, Treatment pattern will be measured by analysing the luteal phase support protocol., Up to 22 days|Number of oocytes retrieved, Number of oocytes retrieved at oocyte retrieval, Up to 22 days|Number of Metaphase II (MII) oocytes, Number of MII oocytes at oocyte retrieval (only applicable for Intracytoplasmic sperm injection (ICSI)), Up to 22 days|Number of embryos, Number of embryos on Day 3 after oocyte retrieved, Day 3 after oocyte retrieval|Number of Blastocysts, Number of Blastocysts on Day 5 after oocyte retrieved, Day 5 after oocyte retrieval|Number of embryos transferred, Embryos transferred in fresh and/or frozen transfer cycles, Up to 28 days|Number of blastocysts transferred, Blastocysts transferred in fresh and/or frozen transfer cycles, Up to 28 days|Implantation rate, Number of gestational sacs, embryos or blastocysts transferred, Up to 28 days|Positive human chorionic gonadotropin (hCG) rate, Positive human chorionic gonadotropin (hCG) rate analysed using serum or urine hCG test 11-15 days after transfer, 11 to 15 days after transfer|Clinical Pregnancy rate, Clinical pregnancy rate (at least 1 gestational sac 4-5 weeks after transfer), 4 to 5 weeks after transfer|Vital Pregnancy, Vital pregnancy rate (at least 1 intrauterine gestational sac with fetal heartbeat 4-5 weeks after transfer), 4 to 5 weeks after transfer|Ongoing pregnancy rate, Ongoing pregnancy rate (at least 1 intrauterine viable fetus 9-11 weeks after transfer), 9 to 11 weeks after transfer|Time to pregnancy, Time to pregnancy from start date of ovarian stimulation to confirmation of clinical pregnancy, 4 to 5 weeks after transfer|Live birth rate, 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., More than 20 weeks after transfer|Multiple pregnancy rate, More than 1 gestational sac with fetal heart beat 4-5 weeks after transfer, 4 to 5 weeks after transfer|Spontaneous abortion rate, 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, Up to 10-11 weeks after transfer|Ectopic pregnancy rate, Ectopic pregnancy is defined as extrauterine gestational sac with or without fetal heart beat as documented by ultrasound or surgery., Up to 10-11 weeks after transfer|Estradiol Hormone levels, Estradiol hormone levels before stimulation and at the end of stimulation day, Up to 20 days|Progesterone Hormone levels, Progesterone hormone levels before stimulation and at the end of stimulation day, Up to 20 days|Cycle cancellation rate and the reason for cycle cancellation, 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), Up to 28 days|Transfer cancellation rate and the reason for transfer cancellation, 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)., Up to 28 days|Frequency and severity of adverse drug reactions (ADRs) and serious adverse events (SAEs), Frequency and severity of ADRs and SAEs as defined by the investigator, During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer|Preventive interventions for ovarian hyperstimulation syndrome (OHSS), 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), 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 ovarian hyperstimulation syndrome (OHSS), Number of subjects with mild / moderate / severe OHSS, defined by the investigator, During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer