ITMCTR2026001658进行中（未招募）Unknown
A multicenter randomized controlled non-inferiority study on Wenyang Lishui Formula for prevention of ovarian hyperstimulation syndrome (OHSS).
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 35（—）
- 性别
- Female
入选标准
- •Translation of Study Inclusion Criteria and Related Definitions
- •Subjects were included if they:
- •Visited the Reproductive Center of Peking University Third Hospital , Peking University First Hospital and Beijing Obstetrics and Gynecology Hospital due to "infertility" for in vitro fertilization (IVF)-assisted reproduction treatment;
- •Underwent controlled ovarian hyperstimulation (COH);
- •Were identified as having a high risk of ovarian hyperstimulation syndrome (OHSS) on the oocyte retrieval day;
- •Had fresh cycle embryo transfer canceled for OHSS prevention.
- •Diagnostic Criteria for Infertility
- •Infertility is a state of subfertility, defined as the failure of a couple to achieve a clinical pregnancy after at least 12 months of regular, unprotected sexual intercourse. Clinical pregnancy refers to the presence of clinical signs of pregnancy, with confirmation by ultrasound of one or more gestational sacs.
- •Population at High Risk of OHSS
- •Referencing the definition used by the Reproductive Center of our hospital, individuals meeting one or more of the following criteria are classified as being at high risk of OHSS:
- •Serum estradiol (E2) level = 15,000 pmol/L on the trigger day;
- •Number of retrieved oocytes = 20;
- •Serum estradiol (E2) level = 10,000 pmol/L and number of retrieved oocytes = 15 on the trigger day.
- •Inclusion Criteria
- •Subjects must meet all the following criteria to be included in the study:
- •(1)Age = 35 years;
- •(2)Body mass index (BMI) < 24 kg/m²;
- •(3)Serum estradiol (E2) level > 3500 pg/mL or number of retrieved oocytes > 15 on the trigger day;
- •(4)Fresh cycle embryo transfer canceled
排除标准
- •(1) Those who do not accept or cannot tolerate traditional Chinese medicine treatment;
- •(2) Those who use drugs that may have a preventive effect on OHSS such as metformin;
- •(3) Those lacking necessary prognostic information;
- •(4) Those who have not signed the informed consent form.
研究者
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