NCT07494877

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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 approximately 300 infertile women aged 20 to 45 years. Participants will be observed and grouped based on whether they receive anticoagulant medications, such as aspirin or heparin sodium, as part of their standard clinical care. The study will track ultrasound-based receptivity indicators and follow up on pregnancy status and outcomes at 45 and 90 days of gestation. This study is purely observational, and all clinical treatment decisions are made independently of the study protocol.

Detailed description

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.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-11-30
• Completion: 2027-12-31
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: China