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NCT Number: NCT06192147

The Phenotype and Clinical Intervention of High BCAA Type of PCOS

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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).

Treatment and study plan

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

Primary outcomes

  1. clinical pregnancy rate

    Time frame: one year

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

Secondary outcomes

  1. Excellent embryo rate

    Time frame: one year

    number of high-quality embryos/number of normal fertilized cleavage embryos × 100%

  2. Fertilization rate

    Time frame: one year

    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)

  3. Early miscarriage rate

    Time frame: one year

    number of natural abortion cycles within 12 weeks of pregnancy/number of clinical pregnancy cycles × 100%

  4. Live birth rate (transplant cycle)

    Time frame: one year

    number of live births/number of transplant cycles × 100%

  5. The incidence of pregnancy complications

    Time frame: one year

    number of pregnancy complications/number of clinical pregnancy cycles × 100%

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Acronym: BCAAPCOS

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 5, 2024
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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