How anticoagulant medicines affect the uterine lining and pregnancy chances in women with infertility
Evaluation of the Effect of Anticoagulant Therapy on Endometrial Receptivity and Pregnancy Outcomes in Patients With Infertility Using an Ultrasound Multimodal System
This study will see if routine anticoagulant medicines like low-dose aspirin or heparin change endometrial receptivity and improve early pregnancy outcomes in women aged 20–45 with infertility.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | Tang-Du Hospital Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT07494877 on ClinicalTrials.gov |
What this trial studies
This is a single-center, prospective observational cohort that will follow about 300 infertile women aged 20–45 who are planning embryo transfer or monitored conception cycles. Participants will be observed in two groups based on whether they receive routine anticoagulant therapy (for example, low-dose aspirin or heparin) as part of their clinical care, with no treatment decisions made by the study team. A multimodal ultrasound system (2D, 3D and Doppler) will be used to measure endometrial thickness, morphology, peristalsis, and blood flow indices during the implantation window. Pregnancy status and outcomes will be followed at roughly 45 and 90 days of gestation to compare ultrasound-based receptivity indicators and early pregnancy results between groups.
Who should consider this trial
Good fit: Women aged 20–45 with a clinical diagnosis of infertility who are planning embryo transfer or monitored conception cycles and can undergo multimodal ultrasound during the implantation window are ideal candidates.
Not a fit: Patients with major congenital uterine anomalies, untreated significant intrauterine lesions, severe systemic illness, or known bleeding disorders are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If positive, the results could help clinicians decide when adding low-dose aspirin or heparin might improve endometrial blood flow and increase early pregnancy rates for some infertile women.
How similar studies have performed: Prior research on low-dose aspirin and heparin in infertility has shown mixed, condition-specific results with modest benefit mainly in selected groups (for example, recurrent implantation failure or certain thrombophilias), so effects are not definitively proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Xi'an, Shaanxi
- Tangdu Hospital, Air Force Medical University — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Principal investigator: Li Zhang, MD — Tang-Du Hospital
- Study coordinator: Li Zhang, MD
- Email: lilyzhang319_20@hotmail.com
- Phone: 86-29-84778860
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.