The Phenotype and Clinical Intervention of High BCAA Type of PCOS

NCT06192147 | Not Yet Recruiting

• 1 other identifier: BCAAPCOS20231219
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome; Accurate classification; High branched chain amino acids

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  Clinical pregnancy patients/(transplant cycle) patients × 100%

  one year

Secondary Outcomes (5)

• Excellent embryo rate

  one year

• Fertilization rate

  one year

• Early miscarriage rate

  one year

• Live birth rate (transplant cycle)

  one year

• The incidence of pregnancy complications

  one year

Study Arms (2)

intervention group

EXPERIMENTAL

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

control group

NO INTERVENTION

basic conventional treatment

Interventions

protein restricted diet combined with vitamin D intervention DIETARY_SUPPLEMENT

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

intervention group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \) 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).

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 5, 2024

Record last verified: 2023-12