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

Recruiting now · Not applicable

Conditions studied: Polycystic Ovarian Syndrome

In brief

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

Key facts

Study ID

NCT06587698

Run by

Peking University Third Hospital

People needed

300

Starts

2024-08-21

Expected to finish

2029-07-01

Last updated by the study team

2024-09-19

Who can join

Age: 20 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Peking University Third Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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