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Clinical Trials in China / NCT06587698
Recruiting Not applicable

Sitagliptin or BeiDouGen Capsule Improve the Pregnancy Outcome in Patients with PCOS

NCT06587698 · tracked via the Priya Life Science China tracker
Sponsor
Peking University Third Hospital
Phase
Not applicable
Started
2024-08-21
Last updated
2024-09-19

Condition(s) studied

Polycystic Ovarian Syndrome

Investigational drug(s) / intervention(s)

Sitagliptin →BeiDouGenSitagliptin+BeiDouGen →

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

Study 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

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
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. Exclusion Criteria: Exclusion criteria (any of the following criteria met will result in exclusion): Pregnant, lactating, or postmenopausal women. Taking weight loss medications or undergoing weight loss surgery in the past 3 months or currently. 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 \-

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University Third Hospital Beijing Beijing Municipality Recruiting

On this site

📄 Januvia (sitagliptin) drug profile →

More Peking University Third Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06587698 on ClinicalTrials.gov ↗ ← All trials in China