drugset / Trial / NCT06571214

Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment

NCT06571214

Phase 4 Not yet recruiting 300 enrolled Nanjing University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-09-01
Primary completion
2026-12-30
Completion
2027-01-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Gonal-f Protein / enzyme biologic 150 iu Subcutaneous
Subject Gonal-f Protein / enzyme biologic 450 iu Subcutaneous
Subject Luveris Protein / enzyme biologic

Indications