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

NCT07494877 | Recruiting

• 1 other identifier: K202508-28
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility

Keywords

Endometrial Receptivity; Anticoagulant Therapy; Multimodal Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Endometrial Thickness

  During the window of implantation (prior to embryo transfer)

• Endometrial Morphological Pattern

  During the window of implantation (prior to embryo transfer)

• Endometrial and Subendometrial Blood Flow Indices

  During the window of implantation (prior to embryo transfer)

• Endometrial Peristalsis Frequency

  During the window of implantation (prior to embryo transfer)

• Early Miscarriage Rate

  Up to 90 days of gestation

Study Arms (2)

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.

Drug: Routine Anticoagulant Therapy (Aspirin or Heparin Sodium)

Conventional Treatment Cohort

Patients in this cohort receive conventional infertility treatment only, without the addition of anticoagulant therapies, as per standard clinical practice.

Interventions

Routine Anticoagulant Therapy (Aspirin or Heparin Sodium) DRUG

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.

Anticoagulant Therapy Cohort

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult female patients, aged 20 to 45 years, who have been clinically diagnosed with infertility. These patients are seeking routine infertility treatments, such as in vitro fertilization (IVF) and embryo transfer or monitored conception cycles, at Tangdu Hospital. The population includes patients who receive standard conventional treatment as well as those who are prescribed adjunctive anticoagulant therapy based on their routine clinical care indications.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital, Air Force Medical University

Xi'an, Shaanxi, 710038, China

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Aspirin; Heparin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Li Zhang, MD

  Tang-Du Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Zhang, MD

CONTACT

86-29-84778860; lilyzhang319_20@hotmail.com

Zhengjun Ma, MM

CONTACT

+86-13072977233; mazhengjun@fmmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available beginning 6 months and ending 36 months following article publication.
• Access Criteria: To gain access, data requestors will need to contact the corresponding author and sign a formal data access agreement.

Locations

CN (1)