Effect of Anticoagulant Therapy on Endometrial Receptivity and Pregnancy Outcomes in Infertility

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 local hemodynamics and endometrial receptivity. However, a systematic, non-invasive, and quantitative evaluation of these therapeutic effects on the endometrium is still required.

Multimodal ultrasound provides a comprehensive, real-time, and non-invasive approach to assessing endometrial dynamics. By integrating conventional 2D ultrasound, 3D ultrasound, and Doppler imaging, this technology can meticulously quantify endometrial parameters, offering valuable predictive insights for clinical pregnancy outcomes.

Study Design and Methodology:

This is a single-center, prospective, observational cohort study. The objective is to evaluate the impact of routine anticoagulant therapy on endometrial receptivity and subsequent pregnancy outcomes in infertile women using an ultrasound multimodal system.

The study plans to enroll approximately 300 eligible infertile women aged 20 to 45 years. Participants will be categorized into two observational cohorts based solely on their routine clinical care plans:

Observation Group: Patients receiving anticoagulant therapy (e.g., aspirin, heparin sodium) in addition to conventional treatment.

Control/Comparison Group: Patients receiving conventional treatment only. Note: The decision to administer anticoagulant therapy is entirely at the discretion of the attending physicians based on clinical indications, independent of this study protocol. This study is strictly observational and involves no protocol-driven interventions.

Data Collection and Assessments:

During the clinically defined window of implantation, all participants will undergo comprehensive multimodal ultrasound examinations. The primary ultrasonographic parameters to be recorded include:

Endometrial thickness and morphological patterns.

Endometrial peristalsis characteristics.

Endometrial and subendometrial blood flow indices, including Vascularization Index (VI), Flow Index (FI), and Vascularization Flow Index (VFI) via 3D power Doppler.

Follow-up and Endpoints:

Following the ultrasound assessments and embryo transfer/conception, participants will be longitudinally followed. The clinical endpoints, specifically the pregnancy status and outcomes, will be rigorously tracked and documented at 45 days and 90 days of gestation. The collected data will be analyzed to determine the correlation between the multimodal ultrasound parameters of endometrial receptivity under anticoagulant therapy and the ultimate pregnancy success rates.

• Endometrial Thickness [Срок оценки: During the window of implantation (prior to embryo transfer)]
• Endometrial Morphological Pattern [Срок оценки: During the window of implantation (prior to embryo transfer)]
• Endometrial and Subendometrial Blood Flow Indices [Срок оценки: During the window of implantation (prior to embryo transfer)]
• Endometrial Peristalsis Frequency [Срок оценки: During the window of implantation (prior to embryo transfer)]
• Early Miscarriage Rate [Срок оценки: Up to 90 days of gestation]