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NCT Number: NCT07029451

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Live Birth Rate per initiated stimulation cycles

    Time frame: Up to 15 months

Secondary outcomes

  1. Serum oestradiol levels

    Time frame: Up to 20 days

    Serum oestradiol levels on days of stimulation initiation (before treatment) and at end-of-stimulation

  2. Progesterone (P4) levels

    Time frame: Up to 20 days

    Progesterone (P4) levels on days of stimulation initiation (before treatment) and at end-of-stimulation

  3. Cycle cancellation rate and reasons for cycle cancellation

    Time frame: Up to 28 days

  4. Number of oocytes retrieved

    Time frame: Up to 22 days

  5. Number of metaphase II (MII) oocytes

    Time frame: Up to 22 days

    Number of metaphase II (MII) oocytes for intracytoplasmic sperm injection (ICSI)

  6. Number of embryos on Day 3 after oocyte retrieval

    Time frame: Day 3 after oocyte retrieval

  7. Number of embryos on Day 5 after oocyte retrieval

    Time frame: Day 5 after oocyte retrieval

  8. Number of transferred embryos

    Time frame: Up to 28 days

  9. Number of transferred blastocysts

    Time frame: Up to 28 days

  10. Transfer cancellation rate and reasons for transfer cancellation

    Time frame: Up to 28 days

  11. Implantation rate

    Time frame: Up to 28 days

    Number of gestational sacs, embryos or blastocysts transferred

  12. Positive beta-human chorionic gonadotropin (βhCG) test rate

    Time frame: 11-15 days after transfer

  13. Clinical pregnancy rate

    Time frame: 4 to 6 weeks after transfer

    At least one intrauterine gestational sac 4-6 weeks after transfer

  14. Vital pregnancy rate

    Time frame: 4 to 6 weeks after transfer

    At least 1 intrauterine gestational sac with fetal heartbeat 4-6 weeks after transfer

  15. Ongoing pregnancy rate

    Time frame: 9 to 11 weeks after transfer

    At least 1 intrauterine viable fetus 9-11 weeks after transfer

  16. Cumulative ongoing pregnancy rate

    Time frame: 9 to 11 days

  17. Time to pregnancy

    Time frame: 4 to 6 weeks after transfer

    Time to pregnancy from stimulation initiation to ongoing pregnancy

  18. Pregnancy loss rate

    Time frame: Up to 10 - 11 weeks after transfer

  19. Live birth rate per initiated stimulation cycles with fresh transfer cycles

    Time frame: More than 20 weeks after transfer

  20. Cumulative live birth rate per initiated stimulation cycles

    Time frame: More than 20 weeks after transfer

  21. 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

  22. 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

  23. Frequency of early OHSS

    Time frame: Up to 9 days after triggering of final follicular maturation

  24. Frequency of late OHSS

    Time frame: Up to 10-11 weeks after transfer

  25. Use of luteinising hormone (LH) surge suppression protocols

    Time frame: Up to 22 days

  26. Daily dose of REKOVELLE

    Time frame: Up to 22 days

    Use of REKOVELLE protocol, including daily dose

  27. Total dose of REKOVELLE

    Time frame: Up to 22 days

    Use of REKOVELLE protocol including total dose

  28. Stimulation duration

    Time frame: Up to 22 days

    Stimulation duration following use of REKOVELLE protocol

  29. Use of any other concomitant ovarian stimulation agent, including daily dose, total dose, and stimulation duration

    Time frame: Up to 22 days

  30. Use of follicle maturation triggering protocol

    Time frame: Up to 22 days

Study contacts

Contact information is provided by the study sponsor or research team.

Global Clinical Compliance

CONTACT

[email protected]

+1 862-286-5200

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

Prospective, Post-authorisation, Multi-centre, Non-interventional Study to Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patterns of Use in Real-world Practice

Acronym: LYCHEE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 19, 2025
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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