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临床试验 NCT07494877 针对不孕症目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情,或在此提出任何问题。
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Effect of Anticoagulant Therapy on Endometrial Receptivity and Pregnancy Outcomes in Infertility 300 观察性

招募中
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临床试验NCT07494877是一项针对不孕症观察研究试验,目前试验状态为招募中。试验始于2025年9月1日,计划招募300名患者。该研究由Tang-Du Hospital主导,预计于2027年12月31日完成。试验数据来源于ClinicalTrials.gov,最后更新时间为2026年3月27日
简要概括
The purpose of this prospective observational cohort study is to evaluate the effect of routine clinical anticoagulant therapy on endometrial receptivity and subsequent pregnancy outcomes in women with infertility. Researchers will utilize an ultrasound multimodal system to systematically assess endometrial parameters, including thickness, morphology, peristalsis, and blood flow indices. The study aims to enroll appr...显示更多
详细描述
Background and Rationale:

Endometrial receptivity plays a pivotal role in the success of embryo implantation for patients with infertility. Impaired endometrial perfusion is considered a significant contributing factor to implantation failure. In routine clinical practice, anticoagulant therapies, such as low-dose aspirin and low molecular weight heparin (e.g., heparin sodium), are frequently utilized to improve loc...

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官方标题

Evaluation of the Effect of Anticoagulant Therapy on Endometrial Receptivity and Pregnancy Outcomes in Patients With Infertility Using an Ultrasound Multimodal System

疾病
不孕症
其他研究标识符
  • K202508-28
NCT编号
实际开始日期
2025-09-01
最近更新发布
2026-03-27
预计完成日期
2027-12-31
计划入组人数
300
研究类型
观察研究
试验状态
招募中
关键词
Endometrial Receptivity
Anticoagulant Therapy
Multimodal Ultrasound
试验组/干预措施
参与者组/试验组干预措施/治疗方法
Anticoagulant Therapy Cohort
Patients in this cohort receive routine clinical anticoagulant therapies (such as low-dose aspirin or low molecular weight heparin) in addition to their conventional infertility treatment. The use of anticoagulants is determined by the attending physician based on standard clinical indications, strictly independent of this observational study protocol.
Routine Anticoagulant Therapy (Aspirin or Heparin Sodium)
Patients receive low-dose aspirin or low molecular weight heparin (e.g., heparin sodium) purely as part of their standard clinical care. The decision to initiate, adjust, or terminate this therapy is made entirely by the attending physician based on clinical indications, strictly independent of this observational study protocol. This is tracked solely as an observational exposure.
Conventional Treatment Cohort
Patients in this cohort receive conventional infertility treatment only, without the addition of anticoagulant therapies, as per standard clinical practice.
不适用
主要终点
结果指标度量标准描述时间框架
Clinical Pregnancy Rate
The clinical pregnancy rate is defined as the proportion of patients with the presence of at least one intrauterine gestational sac with a visible fetal heartbeat, confirmed by transvaginal ultrasound.
Up to 90 days of gestation
次要终点
结果指标度量标准描述时间框架
Endometrial Thickness
The maximum anteroposterior diameter of the endometrium measured in millimeters (mm) in the midsagittal plane using 2D transvaginal ultrasound.
During the window of implantation (prior to embryo transfer)
Endometrial Morphological Pattern
Evaluated via 2D transvaginal ultrasound and classified into three typical patterns: Type A (triple-line pattern), Type B (intermediate isoechogenic pattern), and Type C (homogeneous hyperechogenic pattern) to assess morphological receptivity.
During the window of implantation (prior to embryo transfer)
Endometrial and Subendometrial Blood Flow Indices
Quantitative assessment of local tissue perfusion using 3D power Doppler ultrasound. The parameters measured include Vascularization Index (VI, reflecting vessel density), Flow Index (FI, reflecting blood flow intensity), and Vascularization Flow Index (VFI, a combination of vascularity and flow intensity).
During the window of implantation (prior to embryo transfer)
Endometrial Peristalsis Frequency
The frequency of endometrial wave-like activity (contractions per minute) observed via continuous transvaginal ultrasound scanning for a duration of 3 to 5 minutes.
During the window of implantation (prior to embryo transfer)
Early Miscarriage Rate
The proportion of patients who experience a spontaneous pregnancy loss after the initial ultrasound confirmation of an intrauterine clinical pregnancy, prior to 90 days of gestation.
Up to 90 days of gestation
参与助手
资格标准

适龄参与研究
成人
最低年龄要求
20 Years
适龄性别
女性
  • Female patients aged 20 to 45 years.

Clinically diagnosed with infertility and planning to undergo embryo transfer or monitored conception cycles.

Patients who have complete baseline clinical data and are willing to undergo multimodal ultrasound evaluation of endometrial receptivity during the window of implantation.

Voluntarily agreed to participate in this observational study and signed the informed consent form for data collection.

  • Presence of congenital uterine malformations (e.g., septate uterus, bicornuate uterus, unicornuate uterus) that significantly alter the endometrial cavity.

Presence of untreated severe intrauterine lesions, such as submucosal fibroids, severe intrauterine adhesions, or endometrial polyps that may mechanically interfere with implantation.

Severe underlying systemic diseases, including but not limited to severe liver or kidney dysfunction, or malignant tumors.

Known severe bleeding disorders or strict contraindications to anticoagulant medications (for patients in the routine clinical care setting).

Patients who are unable to cooperate with the transvaginal multimodal ultrasound examination or complete the required follow-up for pregnancy outcomes.

Tang-Du Hospital logoTang-Du Hospital
研究责任方
zhangli, 主要研究者, Associate Chief Physician, Tang-Du Hospital
研究中心联系人
联系人: Li Zhang, MD, 86-29-84778860, [email protected]
联系人: Zhengjun Ma, MM, +86-13072977233, [email protected]
1 位于 1 个国家/地区的研究中心

Shaanxi

Tangdu Hospital, Air Force Medical University, Xi'an, Shaanxi, 710038, China
Li Zhang, MM, 联系人, 86-29-84778860, [email protected]
Zhengjun Ma, MM, 联系人, +86-13072977233, [email protected]
招募中