To Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patterns of Use in Real-world Practice

Not yet recruiting

• Conditions: Infertility

• Registration Number: NCT07029451
• Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-17
• Study First Posted: 2025-06-19
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-27
• Study Start: 2025-07-31
• Primary Completion: 2028-09-30
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 2500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Live Birth Rate per initiated stimulation cycles	Up to 15 months

Secondary Outcome Measures

Name	Time	Method
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 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
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
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
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
Stimulation duration	Up to 22 days	Stimulation duration following use of REKOVELLE protocol
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
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