Improving pregnancy outcomes in women with PCOS using Sitagliptin or BeiDouGen capsules

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effects of Sitagliptin, BeiDouGen capsules, or a combination of both on ovarian function and reproductive outcomes in women diagnosed with polycystic ovary syndrome (PCOS). A total of 300 female participants aged 20-40 who are planning to conceive or are experiencing infertility will be recruited and randomly assigned to one of three treatment groups. The study will involve baseline assessments and a treatment period of three months, during which participants will receive either Sitagliptin, BeiDouGen, or both. The results will help inform future intervention strategies for managing PCOS.

Why it matters

Who can join: the full rules

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

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Where it's running

• Peking University Third Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Jie Qiao, PhD
• Email: myl1995lmy@163.com
• Phone: 15611555481

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.