Infertility
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Ferring Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women who meet all the following criteria are eligible for participation: * At least 20 years of age (including the 20th birthday) when signing informed consent * Prescribed REKOVELLE for the first time in controlled ovarian stimulation for in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycles * Willing and able to provide written informed consent
Exclusion criteria
* Women who meet any of the following criteria are not eligible for participation: * Previously undergone more than 1 controlled ovarian stimulation cycles for IVF or ICSI * Currently participating in an interventional clinical study for which treatment with medication is mandated * Currently undergoing ovarian stimulation for fertility preservation or oocytes donation * Contraindications for the use of REKOVELLE
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live Birth Rate per initiated stimulation cycles | Up to 15 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum oestradiol levels | Up to 20 days | Serum oestradiol levels on days of stimulation initiation (before treatment) and at end-of-stimulation |
| Progesterone (P4) levels | Up to 20 days | Progesterone (P4) levels on days of stimulation initiation (before treatment) and at end-of-stimulation |
| Cycle cancellation rate and reasons for cycle cancellation | Up to 28 days | — |
| Number of oocytes retrieved | Up to 22 days | — |
| Number of metaphase II (MII) oocytes | Up to 22 days | Number of metaphase II (MII) oocytes for intracytoplasmic sperm injection (ICSI) |
| Number of embryos on Day 3 after oocyte retrieval | Day 3 after oocyte retrieval | — |
| Number of embryos on Day 5 after oocyte retrieval | Day 5 after oocyte retrieval | — |
| Number of transferred embryos | Up to 28 days | — |
| Number of transferred blastocysts | Up to 28 days | — |
| Transfer cancellation rate and reasons for transfer cancellation | Up to 28 days | — |
| Implantation rate | Up to 28 days | Number of gestational sacs, embryos or blastocysts transferred |
| Positive beta-human chorionic gonadotropin (βhCG) test rate | 11-15 days after transfer | — |
| Clinical pregnancy rate | 4 to 6 weeks after transfer | At least one intrauterine gestational sac 4-6 weeks after transfer |
| Vital pregnancy rate | 4 to 6 weeks after transfer | At least 1 intrauterine gestational sac with fetal heartbeat 4-6 weeks after transfer |
| Ongoing pregnancy rate | 9 to 11 weeks after transfer | At least 1 intrauterine viable fetus 9-11 weeks after transfer |
| Cumulative ongoing pregnancy rate | 9 to 11 days | — |
| Time to pregnancy | 4 to 6 weeks after transfer | Time to pregnancy from stimulation initiation to ongoing pregnancy |
| Pregnancy loss rate | Up to 10 - 11 weeks after transfer | — |
| Live birth rate per initiated stimulation cycles with fresh transfer cycles | More than 20 weeks after transfer | — |
| Cumulative live birth rate per initiated stimulation cycles | More than 20 weeks after transfer | — |
| Frequency and severity of adverse drug reactions | 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) | 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 | Up to 9 days after triggering of final follicular maturation | — |
| Frequency of late OHSS | Up to 10-11 weeks after transfer | — |
| Use of luteinising hormone (LH) surge suppression protocols | Up to 22 days | — |
| Daily dose of REKOVELLE | Up to 22 days | Use of REKOVELLE protocol, including daily dose |
| Total dose of REKOVELLE | Up to 22 days | Use of REKOVELLE protocol including total dose |
| Stimulation duration | Up to 22 days | Stimulation duration following use of REKOVELLE protocol |
| Use of any other concomitant ovarian stimulation agent, including daily dose, total dose, and stimulation duration | Up to 22 days | — |
| Use of follicle maturation triggering protocol | Up to 22 days | — |
Countries
China
Contacts
CONTACTGlobal Clinical Compliance
STUDY_DIRECTORGlobal Clinical Compliance
Ferring Pharmaceuticals
Outcome results
None listed