Status:
RECRUITING
Sitagliptin or BeiDouGen Capsule Improve the Pregnancy Outcome in Patients with PCOS
Lead Sponsor:
Peking University Third Hospital
Conditions:
Polycystic Ovarian Syndrome
Eligibility:
FEMALE
20-40 years
Phase:
NA
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 repr...
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...
Eligibility Criteria
Inclusion
- 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
- 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
- \-
Key Trial Info
Start Date :
August 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06587698
Start Date
August 21 2024
End Date
July 1 2029
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100000