An observational study in Infertility, sponsored by Ferring Pharmaceuticals. Active, not recruiting at 31 sites in 5 countries. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Ferring Pharmaceuticals · Observational
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 1,526 is above the median of 200 across 714 observational studies indexed under Infertility.
Browse Infertility studies →Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 13 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Approximately 1500 patients prescribed REKOVELLE for the first time for controlled overian stimulation (COS) will be enrolled in the study.
Exclusion Criteria:
Participants prescribed REKOVELLE for the first time for controlled ovarian stimulation.
Drug: REKOVELLE
Individualised dosing regiment of REKOVELLE in routine clinical practice.
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.
Time frame: Up to 12 months
The Luteinising hormone (LH) surge suppression protocol
Treatment pattern will be measured by analysing the Lutenising hormone (LH) surge suppression protocol.
Time frame: Up to 22 days
Daily Dosage
Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of daily dosage.
Time frame: Up to 22 days
Stimulation Duration
Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of stimulation duration.
Time frame: Up to 22 days
Total Dosage
Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of total dosage.
Time frame: Up to 22 days
Trigger Protocol
Treatment pattern will be measured by analysing the trigger protocol.
Time frame: Up to 22 days
Luteal phase support protocol
Treatment pattern will be measured by analysing the luteal phase support protocol.
Time frame: Up to 22 days
Number of oocytes retrieved
Number of oocytes retrieved at oocyte retrieval
Time frame: Up to 22 days
Number of Metaphase II (MII) oocytes
Number of MII oocytes at oocyte retrieval (only applicable for Intracytoplasmic sperm injection (ICSI))
Time frame: Up to 22 days
Number of embryos
Number of embryos on Day 3 after oocyte retrieved
Time frame: Day 3 after oocyte retrieval
Number of Blastocysts
Number of Blastocysts on Day 5 after oocyte retrieved
Time frame: Day 5 after oocyte retrieval
Number of embryos transferred
Embryos transferred in fresh and/or frozen transfer cycles
Time frame: Up to 28 days
Number of blastocysts transferred
Blastocysts transferred in fresh and/or frozen transfer cycles
Time frame: Up to 28 days
Implantation rate
Number of gestational sacs, embryos or blastocysts transferred
Time frame: 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
Time frame: 11 to 15 days after transfer
Clinical Pregnancy rate
Clinical pregnancy rate (at least 1 gestational sac 4-5 weeks after transfer)
Time frame: 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)
Time frame: 4 to 5 weeks after transfer
Ongoing pregnancy rate
Ongoing pregnancy rate (at least 1 intrauterine viable fetus 9-11 weeks after transfer)
Time frame: 9 to 11 weeks after transfer
Time to pregnancy
Time to pregnancy from start date of ovarian stimulation to confirmation of clinical pregnancy
Time frame: 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.
Time frame: More than 20 weeks after transfer
Multiple pregnancy rate
More than 1 gestational sac with fetal heart beat 4-5 weeks after transfer
Time frame: 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
Time frame: 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.
Time frame: Up to 10-11 weeks after transfer
Estradiol Hormone levels
Estradiol hormone levels before stimulation and at the end of stimulation day
Time frame: Up to 20 days
Progesterone Hormone levels
Progesterone hormone levels before stimulation and at the end of stimulation day
Time frame: 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)
Time frame: 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).
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Ferring Pharmaceuticals