Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587698
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Sitagliptin or BeiDouGen Capsule Improve the Pregnancy Outcome in Patients with PCOS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sitagliptin or BeiDouGen Capsule Improve the Pregnancy Outcome in Patients with PCOS
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None