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New treatment option for Polycystic Ovarian Syndrome
Official title Sitagliptin or BeiDouGen Capsule Improve the Pregnancy Outcome in Patients with PCOS
ClinicalTrials.gov ID: NCT06587698
What this study is testing
What is Sitagliptin?
Sitagliptin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for polycystic ovarian syndrome.
Also referred to as brand name:Jie Nuo Wei.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 40, women only
You may be able to join 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)...
- Patients who are regularly followed up at our clinic. No participation in other research projects currently or in the past 3 months.
You likely can't join 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...
- Use of insulin, hypoglycemic drugs, or beta-blockers in the past 3 months. Patients with chronic diseases such as hypertension, gout, hyperuricemia...
- Use of glucocorticoids, anti-androgenic drugs, oral contraceptives, ovulation-inducing drugs, weight loss drugs, or other medications affecting...
- Patients with liver cirrhosis or various severe liver diseases (alanine aminotransferase and/or aspartate aminotransferase exceeding 3 times the...
See the full eligibility 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...
- Patients who are regularly followed up at our clinic. No participation in other research projects currently or in the past 3 months.
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.