Trial Title:
Sitagliptin or BeiDouGen Capsule Improve the Pregnancy Outcome in Patients with PCOS
NCT ID:
NCT06587698
Condition:
Polycystic Ovarian Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Sitagliptin Phosphate
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sitagliptin
Description:
100 mg QD for 3 month
Arm group label:
Sitagliptin
Other name:
brand name:Jie Nuo Wei
Intervention type:
Drug
Intervention name:
BeiDouGen
Description:
60 mg BID for 3 month
Arm group label:
BeiDouGen
Other name:
brand name:Kang xin
Intervention type:
Drug
Intervention name:
Sitagliptin+BeiDouGen
Description:
100 mg Sitagliptin QD plus BeiDouGen 60 mg BID for 3 month
Arm group label:
Sitagliptin+BeiDouGen
Other name:
brand name:Jie Nuo Wei and Kang xin
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 reproductive outcomes, and compare the effect of different treatment
methods, which will provide the basis for PCOS intervention strategy and related research
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 purpose, benefits, and risks of the study to patients in
medical or examination units. PCOS patients who meet the inclusion criteria and do not
meet the exclusion criteria will be registered and given a questionnaire by the research
staff after signing the informed consent form. Physical and blood examinations will be
conducted, and electronic randomization will be performed using the Redcap platform.
Intervention Measures After signing the informed consent form, enrolled patients will be
randomly assigned to the Sitagliptin intervention group, the Bei Dou Gen intervention
group, or the combination therapy group of Sitagliptin and Bei Dou Gen. Before
enrollment, all three groups will undergo baseline assessments including blood routine,
liver and kidney function, blood lipids, endocrine hormones, gynecological ultrasound,
liver ultrasound, and physical examinations.
For participants in the Sitagliptin intervention group, Sitagliptin will be administered
orally at a dose of 100 mg once daily for a treatment period of three months.
Participants in the Bei Dou Gen intervention group will receive Bei Dou Gen capsules
orally at a dose of 60 mg twice daily for a treatment period of three months.
Participants in the combination therapy group will receive both Sitagliptin at a dose of
100 mg once daily and Bei Dou Gen capsules at a dose of 60 mg twice daily for a treatment
period of three months.
Criteria for 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
-
Gender:
Female
Minimum age:
20 Years
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Qiao
Phone:
010-82265080
Email:
jie.qiao@263.net
Start date:
August 21, 2024
Completion date:
July 1, 2029
Lead sponsor:
Agency:
Peking University Third Hospital
Agency class:
Other
Source:
Peking University Third Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06587698
