To Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patterns of Use in Real-world Practice
LYCHEE
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
1 other identifier
observational
2,500
1 country
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2025
Typical duration for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2025
CompletedFirst Posted
Study publicly available on registry
June 19, 2025
CompletedStudy Start
First participant enrolled
August 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2028
January 20, 2026
January 1, 2026
3.2 years
June 10, 2025
January 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Live Birth Rate per initiated stimulation cycles
Up to 15 months
Secondary Outcomes (30)
Serum oestradiol levels
Up to 20 days
Progesterone (P4) levels
Up to 20 days
Cycle cancellation rate and reasons for cycle cancellation
Up to 28 days
Number of oocytes retrieved
Up to 22 days
Number of metaphase II (MII) oocytes
Up to 22 days
- +25 more secondary outcomes
Eligibility Criteria
Women eligible for enrolment in the study are those scheduled for their first REKOVELLE treatment, with no more than one prior COS cycle for IVF or ICSI, and who meet the inclusion and exclusion criteria. Data from approximately 2,500 patients will be collected.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230088, China
Maanshan Maternal and Child Health Care Hospital
Ma’anshan, Anhui, 243031, China
Beijing Obstetrics And Gynecology Hospital Capital Medical University
Beijing, Beijing Municipality, 100006, China
Beijing Chaoyang Hospital (Beijing)
Chaoyang, Beijing Municipality, 100020, China
Peking University First Hospital
Xicheng, Beijing Municipality, 100034, China
6th Affiliated Hospital of Sun Yat Sen University
Guangzhou, Guandong, 510655, China
3rd Affiliated Hospital of Guangzhou Medical University (Guangzhou)
Guangzhou, Guangdong, 510000, China
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041, China
The Second Nanning People's Hospital
Nanning, Guangxi, 530000, China
Tongji Hospital Tongji Medical College of Hust
Wuhan, Hubei, 430034, China
Hubei Maternal and Child Health Hospital
Wuhan, Hubei, 430070, China
Reproductive & Genetic hospital Of CITIC-Xiangya
Changsha, Hunan, 410008, China
1st Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
The Second Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710038, China
Binzhou Medical University Hospital
Binzhou, Shandong, 256600, China
Reproductive Hospital Affiliated to Shandong University
Jinan, Shandong, 250001, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272001, China
Shanghai First Maternal and Child Health Hospital
Shanghai, Shanghai Municipality, 201204, China
Northwest Women's and Children's Hospital
Xi’an, Shanxi, 710061, China
Tianjin Medical University General Hospital (Heping District)
Xiaobailou, Tianjin Municipality, 300052, China
Women's hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006, China
Peking University Third Hospital (Beijing)
Beijing, 100191, China
Zhejiang Provincial People's Hospital
Hangzhou, 310014, China
Jinhua People's Hospital
Jinhua, 321022, China
The Peoples Hospital of Guangxi Zhuang Autonomous Region
Nanning, 530021, China
The Reproduction Hospital of Guangxi Zhuang Autonomous Region
Nanning, 530022, China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, 200032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Compliance
Ferring Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2025
First Posted
June 19, 2025
Study Start
August 5, 2025
Primary Completion (Estimated)
September 30, 2028
Study Completion (Estimated)
September 30, 2028
Last Updated
January 20, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share