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

NCT ID: NCT07029451

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-05

Study Completion Date

2028-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Compliance

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status RECRUITING

Maanshan Maternal and Child Health Care Hospital

Ma’anshan, Anhui, China

Site Status RECRUITING

Beijing Obstetrics And Gynecology Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Chaoyang Hospital (Beijing)

Chaoyang, Beijing Municipality, China

Site Status RECRUITING

Peking University First Hospital

Xicheng, Beijing Municipality, China

Site Status RECRUITING

6th Affiliated Hospital of Sun Yat Sen University

Guangzhou, Guandong, China

Site Status RECRUITING

3rd Affiliated Hospital of Guangzhou Medical University (Guangzhou)

Guangzhou, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

Site Status RECRUITING

The Second Nanning People's Hospital

Nanning, Guangxi, China

Site Status RECRUITING

Tongji Hospital Tongji Medical College of Hust

Wuhan, Hubei, China

Site Status RECRUITING

Hubei Maternal and Child Health Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Reproductive & Genetic hospital Of CITIC-Xiangya

Changsha, Hunan, China

Site Status RECRUITING

1st Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status RECRUITING

The Second Affiliated Hospital of Air Force Medical University

Xi'an, Shaanxi, China

Site Status RECRUITING

Binzhou Medical University Hospital

Binzhou, Shandong, China

Site Status RECRUITING

Reproductive Hospital Affiliated to Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Affiliated Hospital of Jining Medical University

Jining, Shandong, China

Site Status RECRUITING

Shanghai First Maternal and Child Health Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Northwest Women's and Children's Hospital

Xi’an, Shanxi, China

Site Status RECRUITING

Tianjin Medical University General Hospital (Heping District)

Xiaobailou, Tianjin Municipality, China

Site Status RECRUITING

Women's hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Peking University Third Hospital (Beijing)

Beijing, , China

Site Status RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, , China

Site Status RECRUITING

Jinhua People's Hospital

Jinhua, , China

Site Status RECRUITING

The Peoples Hospital of Guangxi Zhuang Autonomous Region

Nanning, , China

Site Status RECRUITING

The Reproduction Hospital of Guangxi Zhuang Autonomous Region

Nanning, , China

Site Status RECRUITING

Zhongshan Hospital Affiliated to Fudan University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Global Clinical Compliance

Role: CONTACT

+1 862-286-5200

Other Identifiers

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000442

Identifier Type: -

Identifier Source: org_study_id

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