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Recruiting NCT07029451

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

— Observational Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Infertility. Basic parameters: from 20 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Primary outcome measures

  • Live Birth Rate per initiated stimulation cycles [Time frame: Up to 15 months]
Secondary outcome measures (12)
  • Serum oestradiol levels [Time frame: Up to 20 days]
  • Progesterone (P4) levels [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 [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 [Time frame: Up to 28 days]
  • Positive beta-human chorionic gonadotropin (βhCG) test rate [Time frame: 11-15 days after transfer]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 28 centers
  • The First Affiliated Hospital of Anhui Medical University — Hefei
  • Maanshan Maternal and Child Health Care Hospital — Ma’anshan
  • Beijing Obstetrics And Gynecology Hospital Capital Medical University — Beijing
  • Beijing Chaoyang Hospital (Beijing) — Chaoyang
  • Peking University First Hospital — Xicheng
  • 6th Affiliated Hospital of Sun Yat Sen University — Guangzhou
  • 3rd Affiliated Hospital of Guangzhou Medical University (Guangzhou) — Guangzhou
  • The First Affiliated Hospital of Shantou University Medical College — Shantou
  • … and 20 more centers

Identifiers

NCT: NCT07029451 · 000442

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗