An observational study in Infertility, sponsored by Ferring Pharmaceuticals. Active, not recruiting at 28 sites in China. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Ferring Pharmaceuticals · Observational
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.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's enrollment of 2,549 is above the median of 200 across 592 observational studies indexed under Infertility.
Browse Infertility studies →Ferring Pharmaceuticals is the lead sponsor of 249 studies on the registry; 4 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 14 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women eligible for enrolment in the study are those scheduled for their first REKOVELLE treatment, with no more than one prior COS cycle for IVF or ICSI, and who meet the inclusion and exclusion criteria. Data from approximately 2,500 patients will be collected.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women who meet all the following criteria are eligible for participation:
Exclusion Criteria:
Women who meet any of the following criteria are not eligible for participation:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Sep 2028, 37 months after the start.
Of 242 observational studies under Infertility, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 100. This study's planned 37 months is close to that.
How these figures are worked out, and which studies are left out of them.
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 ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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