RecruitingNCT07029451

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

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


Sponsor

Ferring Pharmaceuticals

Enrollment

2,500 participants

Start Date

Aug 5, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 20 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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

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Locations(28)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Maanshan Maternal and Child Health Care Hospital

Ma’anshan, Anhui, China

Beijing Obstetrics And Gynecology Hospital Capital Medical University

Beijing, Beijing Municipality, China

Beijing Chaoyang Hospital (Beijing)

Chaoyang, Beijing Municipality, China

Peking University First Hospital

Xicheng, Beijing Municipality, China

6th Affiliated Hospital of Sun Yat Sen University

Guangzhou, Guandong, China

3rd Affiliated Hospital of Guangzhou Medical University (Guangzhou)

Guangzhou, Guangdong, China

The First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

The Second Nanning People's Hospital

Nanning, Guangxi, China

Tongji Hospital Tongji Medical College of Hust

Wuhan, Hubei, China

Hubei Maternal and Child Health Hospital

Wuhan, Hubei, China

Reproductive & Genetic hospital Of CITIC-Xiangya

Changsha, Hunan, China

1st Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

The Second Affiliated Hospital of Air Force Medical University

Xi'an, Shaanxi, China

Binzhou Medical University Hospital

Binzhou, Shandong, China

Reproductive Hospital Affiliated to Shandong University

Jinan, Shandong, China

Affiliated Hospital of Jining Medical University

Jining, Shandong, China

Shanghai First Maternal and Child Health Hospital

Shanghai, Shanghai Municipality, China

Northwest Women's and Children's Hospital

Xi’an, Shanxi, China

Tianjin Medical University General Hospital (Heping District)

Xiaobailou, Tianjin Municipality, China

Women's hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Peking University Third Hospital (Beijing)

Beijing, China

Zhejiang Provincial People's Hospital

Hangzhou, China

Jinhua People's Hospital

Jinhua, China

The Peoples Hospital of Guangxi Zhuang Autonomous Region

Nanning, China

The Reproduction Hospital of Guangxi Zhuang Autonomous Region

Nanning, China

Zhongshan Hospital Affiliated to Fudan University

Shanghai, China

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NCT07029451


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