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

Recruiting now

Conditions studied: Infertility

In brief

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.

Key facts

Study ID

NCT07029451

Run by

Ferring Pharmaceuticals

People needed

2500

Starts

2025-08-05

Expected to finish

2028-09-30

Last updated by the study team

2026-01-20

Who can join

Age: 20 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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