Status:
NOT_YET_RECRUITING
Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment
Lead Sponsor:
Nanjing University
Conditions:
Infertility
Eligibility:
FEMALE
35-40 years
Phase:
PHASE4
Brief 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 pat...
Detailed Description
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 pat...
Eligibility Criteria
Inclusion
- Age 35 to 40 (including 40)
- 5\<BMI\<28 kg/m2
- AFC up to 14
- First or second ART cycle
- Planned for ovarian stimulation with GnRH-antagonist for down-regulation
- Ejaculated sperm
Exclusion
- Contraindications to ART treatment
- History of two or more spontaneous miscarriages
- History of two or more implantation failures after fresh or frozen-warmed embryo transfers
- Diagnosis of severe endometriosis
- Patients with endocrine and metabolic diseases (diabetes mellitus, hypogonadotropic amenorrhea, genital system tumors, hyperprolactinemia, etc.)
- Confirmed chromosomal abnormalities
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06571214
Start Date
September 1 2024
End Date
January 30 2027
Last Update
August 27 2024
Active Locations (1)
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1
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008