Comparing Sitagliptin and BeiDouGen Capsules for Improving Pregnancy Outcomes in Women with Polycystic Ovary Syndrome PCOS

What this Trial Is About

Researchers are evaluating the effects of Sitagliptin, BeiDouGen capsules, or a combination of both on ovarian function and reproductive outcomes in women with polycystic ovary syndrome PCOS. This open-label randomized controlled trial aims to compare these treatment methods to help develop better intervention strategies for PCOS. The study plans to enroll 300 female patients aged 20 to 40 years who are either planning to conceive or are infertile and meet specific diagnostic criteria for PCOS. Participants will be randomly assigned to one of three groups Sitagliptin alone 100 mg once daily, BeiDouGen capsules alone 60 mg twice daily, or a combination of both treatments in the same doses. All treatments will be taken orally for a period of three months. Before starting treatment, participants will undergo baseline assessments including blood tests, hormone levels, ultrasounds, and physical exams. During the study, participants will have their clinical pregnancy rate monitored over an average of two years. Additional evaluations will include hormone levels, ovarian volume, number of follicles, eggs retrieved and matured, fertilization rates, embryo quality, and metabolic markers before and after the three-month treatment period. Safety and treatment effects will be tracked through physical and laboratory exams. The total duration of participation encompasses treatment and follow-up to assess pregnancy outcomes.

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