NCT06587698

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polycystic Ovarian Syndrome

Interventions

Type	Name	Description
DRUG	Sitagliptin	100 mg QD for 3 month
DRUG	BeiDouGen	60 mg BID for 3 month
DRUG	Sitagliptin+BeiDouGen	100 mg Sitagliptin QD plus BeiDouGen 60 mg BID for 3 month

Timeline

• Start date: 2024-08-21
• Primary completion: 2028-07-01
• Completion: 2029-07-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China