Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment
- Conditions
- Infertility
- Registration Number
- NCT06571214
- Lead Sponsor
- Nanjing University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Female
- Target Recruitment
- 300
Inclusion Criteria:<br><br> - Age 35 to 40 (including 40)<br><br> - 18.5<BMI<28 kg/m2<br><br> - AFC up to 14<br><br> - First or second ART cycle<br><br> - Planned for ovarian stimulation with GnRH-antagonist for down-regulation<br><br> - Ejaculated sperm<br><br>Exclusion Criteria:<br><br> - Contraindications to ART treatment<br><br> - History of two or more spontaneous miscarriages<br><br> - History of two or more implantation failures after fresh or frozen-warmed embryo<br> transfers<br><br> - Diagnosis of severe endometriosis<br><br> - Patients with endocrine and metabolic diseases (diabetes mellitus, hypogonadotropic<br> amenorrhea, genital system tumors, hyperprolactinemia, etc.)<br><br> - Confirmed chromosomal abnormalities
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Good quality embryo rate (cleavage stage)
- Secondary Outcome Measures
Name Time Method Number of oocytes;Number of MII oocytes (analyzed in ICSI subgroup only);Total r-hFSH dose;Fertilization rate;Blastocyst development rate;Utilizable embryo rate;Implantation rate;Clinical pregnancy rate (per transfer cycle and per oocyte retrieval cycle);Ongoing pregnancy rate;Ovarian sensitivity index (OSI);Follicular output rate (FORT);Follicle oocyte index (FOI);Safety Assessments