Sitagliptin or BeiDouGen Capsule Improve the Pregnancy Outcome in Patients with PCOS
NCT ID: NCT06587698
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2024-08-21
2029-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sitagliptin
100mg/day Sitagliptin by oral for 3 months
detail：1 piece(100mg) at morning
Sitagliptin
100 mg QD for 3 month
BeiDouGen
120mg/day BeiDouGen capsule by oral for 3 months
detail：2 piece(30mg) at morning and night
BeiDouGen
60 mg BID for 3 month
Sitagliptin+BeiDouGen
100mg/day Sitagliptin+120mg/day BeiDouGen capsule by oral for 3 months
detail：1 piece(100mg) Sitagliptin and 2 piece(30mg) BeiDouGen capsule at morning 2 piece(30mg) BeiDouGen capsule at night
Sitagliptin+BeiDouGen
100 mg Sitagliptin QD plus BeiDouGen 60 mg BID for 3 month
Interventions
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Sitagliptin
100 mg QD for 3 month
BeiDouGen
60 mg BID for 3 month
Sitagliptin+BeiDouGen
100 mg Sitagliptin QD plus BeiDouGen 60 mg BID for 3 month
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
Food allergies. Other diseases that may cause hyperandrogenism or ovulation abnormalities (e.g., Cushing's syndrome, non-classical congenital adrenal hyperplasia, tumors secreting androgens in the ovaries or adrenal glands, functional hypothalamic amenorrhea, thyroid diseases, hyperprolactinemia, premature ovarian insufficiency, etc.).
Use of insulin, hypoglycemic drugs, or beta-blockers in the past 3 months. Patients with chronic diseases such as hypertension, gout, hyperuricemia, diabetes, etc., requiring regular medication.
Use of glucocorticoids, anti-androgenic drugs, oral contraceptives, ovulation-inducing drugs, weight loss drugs, or other medications affecting hormone levels, appetite, and carbohydrate metabolism in the past 2 months.
Patients with liver cirrhosis or various severe liver diseases (alanine aminotransferase and/or aspartate aminotransferase exceeding 3 times the upper limit of normal), patients with abnormal renal function (serum creatinine exceeding the upper limit of normal), patients with kidney disease or other diseases requiring control of protein intake.
Patients currently or previously with severe cardiovascular and cerebrovascular diseases that may interfere with the normal conduct of the trial (such as heart failure, myocardial infarction, cerebral infarction, acute myocarditis, severe arrhythmias, patients undergoing interventional therapy, etc.).
Patients currently with severe gastrointestinal diseases such as gastrointestinal ulcer bleeding, chronic diarrhea, or who have undergone gastrointestinal resection surgery, which may affect nutrient absorption.
Patients with infectious diseases such as hepatitis B e antigen-positive, active pulmonary tuberculosis, or HIV.
Cancer patients or those who have received radiation and chemotherapy within the past five years.
Patients with any psychological or psychiatric disorders requiring medication, including epilepsy patients or those undergoing antiepileptic treatment, patients using antidepressants, etc.
Daily alcohol consumption exceeding 15g. Smoking habit
\-
20 Years
40 Years
FEMALE
No
Sponsors
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Peking University Third Hospital
OTHER
Responsible Party
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Principal Investigators
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Jie Qiao
Role: STUDY_CHAIR
the third hospital of peking universry
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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M2024342
Identifier Type: -
Identifier Source: org_study_id
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