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Background Polycystic ovary syndrome (PCOS) is defined as a complex endocrine syndrome and the mechanisms underlying its various clinical signs and symptoms are still poorly understood, brings huge difficulties for clinical diagnosis and treatment. General agreement based on several clinical guideline[1, 2] suggest that it is critical to precisely diagnose the phenotypes of PCOS and give them an individual therapy. However, the criteria for different phenotypes remains unclear, mostly based on symptoms, physical examination and laboratory evaluation. The aim of this study is to compare the accuracy and preciseness of metabolomics markers with common clinical characteristics to find a more effective way to diagnose and treat these two subgroups (based on our basic study[3]) of PCOS patients. What’s more, the effects of different interventions according to two subgroups will also be observed. Methods/design This is a prospective, multicenter, analyst-blinded and randomized controlled trial. One healthy control group and two parallel experiment arms will be proposed in this study: (1) people without PCOS (health control group); (2) PCOS patients diagnosed mainly based on clinical indexes (group one); (3) PCOS patients diagnosed mainly based on metabolomics indexes (group two). A total of 276 eligible people will be recruited, which includes 60 healthy people and 216 PCOS patients, which will be randomly assigned to different diagnosis groups in a 1:1 ratio. Patients in two different diagnosis groups will be divided into two different subgroups according to their clinical characteristics (group one based on clinical indexes, group two based on metabolomics indexes) and receive a 6-month corresponding treatment. The primary outcome for experiment groups will be the condition of PCOS. All data will be analyzed periodically. This trial will help us to clarify the value of metabolomics integrated with clinical characteristics in diagnosis and treatment of two PCOS subgroups. It will also highlight any differences in the accuracy and efficacy of these two techniques and it may provide a new specific direction of integrated method for the PCOS therapy. Discussion The purpose of this trial is to determine whether integrated metabolomics indexes is more accuracy and effective than clinical characteristics in diagnose the phenotypes of reproductive females with PCOS. This trial will, therefore, contribute to providing a solid foundation for clinical precise diagnosis of two PCOS subgroups, as well as future research in PCOS individual therapy. |
