The Phenotype and Clinical Intervention of High BCAA Type of PCOS (BCAAPCOS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Dietary supplement: protein restricted diet combined with vitamin D intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

The included population is PCOS patients who are seeking their first IVF treatment at the Reproductive Medicine Center of Peking University Third Hospital, aged 20-40 years old. PCOS diagnosis meets two of the following three criteria based on the 2003 Rotterdam criteria: clinical manifestations of oligomenorrhea and/or amenorrhea, hyperandrogenism or hyperandrogenism (hirsutism, acne, etc.), PCO like changes in the ovaries under ultrasound, while excluding diseases such as hyperprolactinemia, congenital adrenal hyperplasia, Cushing syndrome, and androgen secreting tumors. All selected subjects have no medical history of taking steroid drugs within 3 months.

Exclusion Criteria:

1) Refusing to sign informed consent or unable to follow up on time; 2) Severe complications requiring cessation of treatment (>2 weeks) or termination of treatment; 3) Patients should take vitamin D orally before enrollment (baseline data still needs to be recorded for later statistical analysis); 4) Any unstable or medical condition that affects patient safety and research compliance. 5) Male partners have severe male infertility factors; 6) Patients undergoing embryo analysis using pre implantation genetic testing techniques (PGT-A/SR/M).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; On the basis of conventional treatment, a protein restricted diet combined with vitamin D intervention plan is given	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
No Intervention: control group; basic conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy rate	Clinical pregnancy patients/(transplant cycle) patients × 100%	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Excellent embryo rate	number of high-quality embryos/number of normal fertilized cleavage embryos × 100%	one year
Fertilization rate	number of fertilized eggs/number of retrieved eggs × 100% Implantation rate=number of gestational sacs/total number of transplanted embryos × 100% (the number of gestational sacs in a single embryo transfer is only counted as 1)	one year
Early miscarriage rate	number of natural abortion cycles within 12 weeks of pregnancy/number of clinical pregnancy cycles × 100%	one year
Live birth rate (transplant cycle)	number of live births/number of transplant cycles × 100%	one year
The incidence of pregnancy complications	number of pregnancy complications/number of clinical pregnancy cycles × 100%	one year

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Polycystic Ovary Syndrome; Accurate classification; High branched chain amino acids
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Syndrome; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: BCAAPCOS20231219

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No