NCT06587698Recruiting
Sitagliptin or BeiDouGen Capsule Improve the Pregnancy Outcome in Patients with PCOS
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 25 Jul 2024
- Start date
- Aug 2024
- Primary completion date
- Jul 2028
- Lead sponsor
- Peking University Third Hospital
- NCT number
- NCT06587698
What you commit to
- Study type: Interventional
- Planned participants: 300
- From Aug 2024 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnant, lactating, or postmenopausal women. Taking weight loss medications or undergoing weight loss surgery in the past 3 months or currently.
- 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 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.).
- Cancer patients or those who have received radiation and chemotherapy within the past five years.
Other illness
- 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.
- 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.
- Patients with any psychological or psychiatric disorders requiring medication, including epilepsy patients or those undergoing antiepileptic treatment, patients using antidepressants, etc.
Lab values
- 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.
Other
- Daily alcohol consumption exceeding 15g. Smoking habit
- \-
Who the study is looking for
- 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.
Age in the registry: 20 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.