REKOVELLE use in Chinese women undergoing IVF or ICSI

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

This project will see how REKOVELLE is used and performs for Chinese women having IVF or ICSI in routine clinical care.

Quick facts

• Study type: Observational
• Enrollment: 2500 (estimated)
• Ages: 20 Years and up
• Sex: Female
• Sponsor: Ferring Pharmaceuticals (Industry-sponsored)
• Locations: 28 sites (Hefei, Anhui and 27 other locations)
• Trial ID: NCT07029451 on ClinicalTrials.gov

What this trial studies

This is a prospective, multi-center, non-interventional cohort following about 2,500 women prescribed REKOVELLE for controlled ovarian stimulation in routine IVF or ICSI cycles across 30–50 sites in China. Investigators will collect real-world data on dosing patterns, treatment outcomes, and safety events over a total study period of roughly 35 months. Eligible participants are adult women receiving REKOVELLE for the first time in an IVF/ICSI cycle and able to give written consent, with several exclusions such as oocyte donation or fertility preservation cycles. Data will be summarized descriptively to characterize patterns of use and capture adverse events as observed in everyday practice.

Who should consider this trial

Good fit: Women aged 20 or older who are being prescribed REKOVELLE for the first time for controlled ovarian stimulation in an IVF or ICSI cycle and can provide written informed consent are ideal candidates.

Not a fit: Women under 20, those undergoing fertility preservation or oocyte donation, those with contraindications to REKOVELLE, or those already enrolled in mandated interventional drug trials are unlikely to be eligible or to gain direct benefit from participation.

Why it matters

Potential benefit: If successful, this work could provide clinicians in China with real-world safety and use information to help optimize REKOVELLE dosing and management during ovarian stimulation.

How similar studies have performed: Randomized trials and some observational cohorts have provided supportive safety and effectiveness data for REKOVELLE (follitropin delta), but real-world evidence specifically in routine practice among Chinese women is limited.

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

Where this trial is running

Hefei, Anhui and 27 other locations

• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
• Maanshan Maternal and Child Health Care Hospital — Ma’anshan, Anhui, China (Recruiting)
• Beijing Obstetrics And Gynecology Hospital Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• Beijing Chaoyang Hospital (Beijing) — Chaoyang, Beijing Municipality, China (Recruiting)
• Peking University First Hospital — Xicheng, Beijing Municipality, China (Recruiting)
• 6th Affiliated Hospital of Sun Yat Sen University — Guangzhou, Guandong, China (Recruiting)
• 3rd Affiliated Hospital of Guangzhou Medical University (Guangzhou) — Guangzhou, Guangdong, China (Recruiting)
• The First Affiliated Hospital of Shantou University Medical College — Shantou, Guangdong, China (Recruiting)
• The Second Nanning People's Hospital — Nanning, Guangxi, China (Recruiting)
• Tongji Hospital Tongji Medical College of Hust — Wuhan, Hubei, China (Recruiting)
• Hubei Maternal and Child Health Hospital — Wuhan, Hubei, China (Recruiting)
• Reproductive & Genetic hospital Of CITIC-Xiangya — Changsha, Hunan, China (Recruiting)
• 1st Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• General Hospital of Ningxia Medical University — Yinchuan, Ningxia, China (Recruiting)
• The Second Affiliated Hospital of Air Force Medical University — Xi'an, Shaanxi, China (Recruiting)
• Binzhou Medical University Hospital — Binzhou, Shandong, China (Recruiting)
• Reproductive Hospital Affiliated to Shandong University — Jinan, Shandong, China (Recruiting)
• Affiliated Hospital of Jining Medical University — Jining, Shandong, China (Recruiting)
• Shanghai First Maternal and Child Health Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Northwest Women's and Children's Hospital — Xi’an, Shanxi, China (Recruiting)
• Tianjin Medical University General Hospital (Heping District) — Xiaobailou, Tianjin Municipality, China (Recruiting)
• Women's hospital School of Medicine Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
• Peking University Third Hospital (Beijing) — Beijing, China (Recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, China (Recruiting)
• Jinhua People's Hospital — Jinhua, China (Recruiting)
• The Peoples Hospital of Guangxi Zhuang Autonomous Region — Nanning, China (Recruiting)
• The Reproduction Hospital of Guangxi Zhuang Autonomous Region — Nanning, China (Recruiting)
• Zhongshan Hospital Affiliated to Fudan University — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Global Clinical Compliance

Conditions Infertility