Prospective, Multi-centre, Non-Interventional Study to Investigate the Effectiveness of REKOVELLE® for Ovarian Stimulation for Asian Women in Real World Settings

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.

Treatment pattern will be measured by analysing the Lutenising hormone (LH) surge suppression protocol.

Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of daily dosage.

Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of stimulation duration.

Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of total dosage.

Treatment pattern will be measured by analysing the trigger protocol.

Treatment pattern will be measured by analysing the luteal phase support protocol.

Number of oocytes retrieved at oocyte retrieval

Number of MII oocytes at oocyte retrieval (only applicable for Intracytoplasmic sperm injection (ICSI))

Number of embryos on Day 3 after oocyte retrieved

Number of Blastocysts on Day 5 after oocyte retrieved

Embryos transferred in fresh and/or frozen transfer cycles

Blastocysts transferred in fresh and/or frozen transfer cycles

Number of gestational sacs, embryos or blastocysts transferred

Positive human chorionic gonadotropin (hCG) rate analysed using serum or urine hCG test 11-15 days after transfer

Clinical pregnancy rate (at least 1 gestational sac 4-5 weeks after transfer)

Vital pregnancy rate (at least 1 intrauterine gestational sac with fetal heartbeat 4-5 weeks after transfer)

Ongoing pregnancy rate (at least 1 intrauterine viable fetus 9-11 weeks after transfer)

Time to pregnancy from start date of ovarian stimulation to confirmation of clinical pregnancy

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 1 gestational sac with fetal heart beat 4-5 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

Ectopic pregnancy is defined as extrauterine gestational sac with or without fetal heart beat as documented by ultrasound or surgery.

Estradiol hormone levels before stimulation and at the end of stimulation day

Progesterone hormone levels before stimulation and at the end of stimulation day

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)

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).

Frequency and severity of ADRs and SAEs as defined by the investigator

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 OHSS, defined by the investigator