This study will be carried out under the guidance of professional doctor, patients with PCOS will be treated with Sitagliptin or BeiDouGen capsule or both two to assess their ovarian function and reproductive outcomes, and compare the effect of different treatment methods, which will provide the basis for PCOS intervention strategy and related research
Subject Recruitment and Grouping This study adopts an open-label randomized controlled trial design. We plan to recruit a total of 300 patients with polycystic ovary syndrome (PCOS) by introducing the purpose, benefits, and risks of the study to patients in medical or examination units. PCOS patients who meet the inclusion criteria and do not meet the exclusion criteria will be registered and given a questionnaire by the research staff after signing the informed consent form. Physical and blood examinations will be conducted, and electronic randomization will be performed using the Redcap platform. Intervention Measures After signing the informed consent form, enrolled patients will be randomly assigned to the Sitagliptin intervention group, the Bei Dou Gen intervention group, or the combination therapy group of Sitagliptin and Bei Dou Gen. Before enrollment, all three groups will undergo baseline assessments including blood routine, liver and kidney function, blood lipids, endocrine hormones, gynecological ultrasound, liver ultrasound, and physical examinations. For participants in the Sitagliptin intervention group, Sitagliptin will be administered orally at a dose of 100 mg once daily for a treatment period of three months. Participants in the Bei Dou Gen intervention group will receive Bei Dou Gen capsules orally at a dose of 60 mg twice daily for a treatment period of three months. Participants in the combination therapy group will receive both Sitagliptin at a dose of 100 mg once daily and Bei Dou Gen capsules at a dose of 60 mg twice daily for a treatment period of three months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
100 mg QD for 3 month
60 mg BID for 3 month
100 mg Sitagliptin QD plus BeiDouGen 60 mg BID for 3 month
Peking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGClinical pregnancy rate
the pregnancy situation among volunteers
Time frame: through study completion, an average of 2 year
DHEA
dehydroepiandrosteron in serum during menstruation period
Time frame: before and after intervention(3 month)
total testosterone
total testosterone in serum during menstruation period
Time frame: before and after intervention(3 month)
FAI
Free testosterone index calculated by total testosterone and SHBG
Time frame: before and after intervention(3 month)
LH/FSH
the rate between LH and FSH
Time frame: before and after intervention(3 month)
ovarian volume
the size is measured by ultrasound
Time frame: before and after intervention(3 month)
number of antral follicles
the number is is measured by ultrasound during menstruation period
Time frame: before and after intervention(3 month)
Number of retrieved eggs
the number is observed during the surgery
Time frame: after intervention(3 month)
number of mature eggs (MII)
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observed the state of oocytes during the IVF laboratory
Time frame: after intervention(3 month)
fertilization rate
observed the state of oocytes during the IVF laboratory
Time frame: after intervention(3 month)
number of usable embryos,
observed the state of embryos during the IVF laboratory
Time frame: after intervention(3 month)
number of high-quality embryos
observed the state of embryos during the IVF laboratory
Time frame: after intervention(3 month)
GLP-1 levels
measure it in the serum
Time frame: before and after intervention(3 month)
fasting glucose
measured by glucometer
Time frame: before and after intervention(3 month)
OGTT
measured by glucometer
Time frame: before and after intervention(3 month)
HOMA index
calculated by glucose and INS
Time frame: before and after intervention(3 month)