InfertilityNCT07494877
Effect of Anticoagulant Therapy on Endometrial Receptivity and Pregnancy Outcomes in Infertility
An observational study of Infertility, run by Tang-Du Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Routine Anticoagulant Therapy (Aspirin or Heparin Sodium)
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tangdu Hospital, Air Force Medical University
Xi'an, Shaanxi, 710038
Li Zhang, MM, 86-29-84778860, lilyzhang319_20@hotmail.com
Zhengjun Ma, MM, +86-13072977233, mazhengjun@fmmu.edu.cn
About this study
Official title: Evaluation of the Effect of Anticoagulant Therapy on Endometrial Receptivity and Pregnancy Outcomes in Patients With Infertility Using an Ultrasound Multimodal System
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.
Read the 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
- Being tested
- Routine Anticoagulant Therapy (Aspirin or Heparin Sodium)
- Keywords
- Endometrial Receptivity, Anticoagulant Therapy, Multimodal Ultrasound
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 90 days of gestation
Secondary outcomes (5)
Endometrial Thickness
The maximum anteroposterior diameter of the endometrium measured in millimeters (mm) in the midsagittal plane using 2D transvaginal ultrasound.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to 90 days of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Sep 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhangli, Tang-Du Hospital
- Investigators
- Li Zhang, MD, Principal investigator, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494877
- Sponsor's protocol ID
- K202508-28
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in the published article will be shared. Data will be available to researchers who provide a methodologically sound proposal, purely for the purpose of achieving the aims in the approved proposal.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Anticoagulant Therapy on Endometrial Receptivity and Pregnancy Outcomes in Patients With Infertility Using an Ultrasound Multimodal System
- ClinicalTrials.gov ID
- NCT07494877
- Acronym / sponsor ID
- K202508-28
- Conditions
- Infertility
- Keywords
- Endometrial Receptivity, Anticoagulant Therapy, Multimodal Ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anticoagulant Therapy Cohort | – | Drug: Routine Anticoagulant Therapy (Aspirin or Heparin Sodium)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. |
| Conventional Treatment Cohort | – | –Patients in this cohort receive conventional infertility treatment only, without the addition of anticoagulant therapies, as per standard clinical practice. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Anticoagulant Therapy Cohort |
Primary outcome
Clinical Pregnancy Rate
Time frame: Up to 90 days of gestation
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.
5 secondary outcomes
Endometrial Thickness
Time frame: During the window of implantation (prior to embryo transfer)
Endometrial Morphological Pattern
Time frame: During the window of implantation (prior to embryo transfer)
Endometrial and Subendometrial Blood Flow Indices
Time frame: During the window of implantation (prior to embryo transfer)
Endometrial Peristalsis Frequency
Time frame: During the window of implantation (prior to embryo transfer)
Early Miscarriage Rate
Time frame: Up to 90 days of gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in the published article will be shared. Data will be available to researchers who provide a methodologically sound proposal, purely for the purpose of achieving the aims in the approved proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Zhang, MD principal investigator
Tang-Du Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Zhang, MD (86-29-84778860, lilyzhang319_20@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy Rate (time frame: Up to 90 days of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.