Polycystic Ovarian Syndrome
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGSitagliptin
100 mg QD for 3 month
DRUGBeiDouGen
60 mg BID for 3 month
DRUGSitagliptin+BeiDouGen
100 mg Sitagliptin QD plus BeiDouGen 60 mg BID for 3 month
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Female patients aged 20-40 years who plan to conceive or are infertile in our center. Diagnosed with PCOS according to the Rotterdam criteria: Diagnosis of PCOS can be made if two out of the following three criteria are met: (1) Oligoovulation or anovulation, (2) Clinical or biochemical signs of hyperandrogenism, (3) Polycystic ovaries on ultrasound examination. Patients who are regularly followed up at our clinic. No participation in other research projects currently or in the past 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | through study completion, an average of 2 year | the pregnancy situation among volunteers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total testosterone | before and after intervention（3 month） | total testosterone in serum during menstruation period |
| FAI | before and after intervention（3 month） | Free testosterone index calculated by total testosterone and SHBG |
| LH/FSH | before and after intervention（3 month） | the rate between LH and FSH |
| ovarian volume | before and after intervention（3 month） | the size is measured by ultrasound |
| number of antral follicles | before and after intervention（3 month） | the number is is measured by ultrasound during menstruation period |
| Number of retrieved eggs | after intervention（3 month） | the number is observed during the surgery |
| number of mature eggs (MII) | after intervention（3 month） | observed the state of oocytes during the IVF laboratory |
| DHEA | before and after intervention（3 month） | dehydroepiandrosteron in serum during menstruation period |
| number of usable embryos, | after intervention（3 month） | observed the state of embryos during the IVF laboratory |
| number of high-quality embryos | after intervention（3 month） | observed the state of embryos during the IVF laboratory |
| GLP-1 levels | before and after intervention（3 month） | measure it in the serum |
| fasting glucose | before and after intervention（3 month） | measured by glucometer |
| OGTT | before and after intervention（3 month） | measured by glucometer |
| HOMA index | before and after intervention（3 month） | calculated by glucose and INS |
| fertilization rate | after intervention（3 month） | observed the state of oocytes during the IVF laboratory |
Countries
China
Contacts
Primary ContactJie Qiao, PhD
Outcome results
None listed