NCT06192147

The Phenotype and Clinical Intervention of High BCAA Type of PCOS

The Phenotype and Clinical Intervention of High Branched Chain Amino Acid Type of Polycystic Ovary Syndrome

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Polycystic ovary syndrome is one of the main diseases leading to infertility in women of childbearing age. In addition to endocrine and reproductive dysfunction, it is often accompanied by significant metabolic abnormalities, which seriously affect long-term health and quality of life. Our preliminary research found that 68% of PCOS patients have significantly increased branched chain amino acid content, accompanied by a decrease in clinical pregnancy rate and an increase in miscarriage rate, which poses challenges to the diagnosis and treatment of PCOS. Based on this, we propose a new PCOS typing strategy that uses the concentration of branched chain amino acids as an evaluation indicator to diagnose high branched chain amino acid PCOS, where the serum BCAA concentration is higher than 405 μ Mol/L is diagnosed as high branched chain amino acid PCOS. According to the different degrees of elevation of branched chain amino acids, they are further divided into common type and ultra-high type, and the impact of different concentrations of branched chain amino acids on pregnancy outcomes, pregnancy complications, and newborns after assisted reproductive technology is analyzed; Based on the typical clinical and metabolic phenotypes of high branched chain amino acid type PCOS patients, corresponding intervention strategies are formulated. By analyzing the clinical pregnancy outcomes, pregnancy complications, and neonatal conditions of patients in the combination intervention group (protein restricted diet combined with vitamin D supplementation) and the conventional treatment group, safe and effective intervention methods are determined.

Detailed description

Based on this, we propose a new PCOS typing strategy that uses the concentration of branched chain amino acids as an evaluation indicator to diagnose high branched chain amino acid PCOS, where the serum BCAA concentration is higher than 405 μ Mol/L is diagnosed as high branched chain amino acid PCOS. According to the different degrees of elevation of branched chain amino acids, they are further divided into common type and ultra-high type, and the impact of different concentrations of branched chain amino acids on pregnancy outcomes, pregnancy complications, and newborns after assisted reproductive technology is analyzed; Based on the typical clinical and metabolic phenotypes of high branched chain amino acid type PCOS patients, corresponding intervention strategies are formulated. By analyzing the clinical pregnancy outcomes, pregnancy complications, and neonatal conditions of patients in the combination intervention group (protein restricted diet combined with vitamin D supplementation) and the conventional treatment group, safe and effective intervention methods are determined.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	protein restricted diet combined with vitamin D intervention	On the basis of conventional treatment, a protein restricted diet combined with vitamin D intervention plan is given

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2024-01-05
• Last updated: 2024-01-05