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

NCT07029451 · tracked via the Priya Life Science China tracker

Sponsor

Ferring Pharmaceuticals

Phase

Observational

Started

2025-08-05

Last updated

2026-01-20

Condition(s) studied

Infertility

Study 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

FEMALE

Min age

20 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Live Birth Rate per initiated stimulation cycles — Up to 15 months

Trial sites (28)

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

Other trials for the same condition

Standardization and Application of Pure Platelet-Rich Plasma in Improving Sperm Function Starting soon

Effectiveness of Generic Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a Gonadotropin-releasing Hormone（GnRH）Antagonist Protocol in Women Undergoing IVF Recruiting

Comparing FET Guided by ERA Vs Standard Timing in Patients with Recurrent Implantation Failure Recruiting

Long-term Follow-up Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference Active, not recruiting

The Efficacy of Remimazolam on Incidence of Hypoxia During Sedated Transvaginal Oocyte Retrieval: A Multicenter Randomized Controlled Trial. Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07029451 on ClinicalTrials.gov ↗ ← All trials in China