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

Ferring

Status: Enrolling

Conditions: Infertility

Study type: Observational

Funder types: Industry

Identifiers

NCT07029451

000442

Details and patient eligibility

About

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.

Enrollment: 2,500 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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