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

NCT06587698 | Recruiting DMC

• 1 other identifier: M2024342
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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 reproductive outcomes, and compare the effect of different treatment methods, which will provide the basis for PCOS intervention strategy and related research

Conditions

Polycystic Ovarian Syndrome

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  the pregnancy situation among volunteers

  through study completion, an average of 2 year

Secondary Outcomes (15)

• DHEA

  before and after intervention（3 month）

• total testosterone

  before and after intervention（3 month）

• FAI

  before and after intervention（3 month）

• LH/FSH

  before and after intervention（3 month）

• ovarian volume

  before and after intervention（3 month）

Study Arms (3)

Sitagliptin

OTHER

100mg/day Sitagliptin by oral for 3 months detail：1 piece(100mg) at morning

Drug: Sitagliptin

BeiDouGen

OTHER

120mg/day BeiDouGen capsule by oral for 3 months detail：2 piece(30mg) at morning and night

Drug: BeiDouGen

Sitagliptin+BeiDouGen

OTHER

100mg/day Sitagliptin+120mg/day BeiDouGen capsule by oral for 3 months detail：1 piece(100mg) Sitagliptin and 2 piece(30mg) BeiDouGen capsule at morning 2 piece(30mg) BeiDouGen capsule at night

Drug: Sitagliptin+BeiDouGen

Interventions

Sitagliptin DRUG

100 mg QD for 3 month

Also known as: brand name:Jie Nuo Wei

Sitagliptin

BeiDouGen DRUG

60 mg BID for 3 month

Also known as: brand name:Kang xin

BeiDouGen

Sitagliptin+BeiDouGen DRUG

100 mg Sitagliptin QD plus BeiDouGen 60 mg BID for 3 month

Also known as: brand name:Jie Nuo Wei and Kang xin

Sitagliptin+BeiDouGen

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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) 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Sitagliptin Phosphate; xin-kang

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Jie Qiao

  the third hospital of peking universry

  STUDY CHAIR

Central Study Contacts

Jie Qiao, PhD

CONTACT

15611555481; myl1995lmy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: September 19, 2024
• Study Start: August 21, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: September 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)