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Effect of Anticoagulant Therapy on Endometrial Receptivity and Pregnancy Outcomes in Infertility 300 Observational
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...
Show MoreEvaluation of the Effect of Anticoagulant Therapy on Endometrial Receptivity and Pregnancy Outcomes in Patients With Infertility Using an Ultrasound Multimodal System
- K202508-28
Anticoagulant Therapy
Multimodal Ultrasound
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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. | N/A |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
- 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 HospitalShaanxi