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

Launched by PEKING UNIVERSITY THIRD HOSPITAL · Sep 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how two different treatments, Sitagliptin and BeiDouGen capsules, can help improve pregnancy outcomes for women with Polycystic Ovarian Syndrome (PCOS). PCOS is a condition that can cause irregular periods and difficulties with ovulation, which may affect a woman's ability to conceive. The researchers hope to find out which treatment works better for improving ovarian function and helping women achieve their pregnancy goals.

To participate in this study, women between the ages of 20 and 40 who are trying to conceive or have been diagnosed with infertility due to PCOS may be eligible. To qualify, participants must meet certain criteria, such as showing signs of irregular ovulation or having polycystic ovaries confirmed by an ultrasound. Participants will receive treatment under the care of a doctor, and the study will provide valuable information that could help improve future treatments for women with PCOS. It's important to note that certain health conditions or medications may disqualify someone from participating, so anyone interested should discuss their individual situation with their healthcare provider.

Gender

FEMALE

Eligibility criteria

• 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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