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Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment
Sponsor: Nanjing University
Summary
This will be an exploratory, prospective, randomized, open-label and controlled trial to evaluate the potential benefit of r-hFSH:r-hLH 2:1 co-treatment starting from COS D1 versus r-hFSH alone in patients aged 35 to 40 under ovarian stimulation treatment. After signing informed consent form (ICF), all eligible participants will be randomly assigned in a 1:1 ratio to either treatment or control group, and GnRH antagonist protocol will be used in both treatment and control groups.
Official title: An Exploratory, Randomized, Open-label, Controlled Study to Evaluate the Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment
Key Details
Gender
FEMALE
Age Range
35 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2024-09-01
Completion Date
2027-01-30
Last Updated
2024-08-27
Healthy Volunteers
No
Conditions
Interventions
Recombinant Human Follitropin Alfa Solution for Injection (Gonal-f®)
As a r-hFSH agent, Gonal-f® is used for COS. It is a prefilled ready to use pen device containing follitropin alfa for injection and is designed for subcutaneous self-administration by patients undergoing COS for ART. It is available as dose presentations of 150 IU and 450 IU. The investigators and/or his/her delegate/s will explain the use of Gonal-f® prefilled pen. Gonal-f® will be prescribed by the investigator based on clinical diagnosis and treatment routines, and will not be provided free of charge.
Recombinant Human Lutropin alfa for Injection (r-hLH, Luveris®)
This product is a white freeze-dried powder and a colorless and clear injection solvent, and stored away from light under 25℃ in the original packaging. Luveris® will be provided free of charge.
Locations (1)
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China