Effect of Anticoagulant Therapy on Endometrial Receptivity and Pregnancy Outcomes in Infertility
ConditionInfertility
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-45
SponsorTang-Du Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged 20 to 45 years.
Disqualifiers
Presence of congenital uterine malformations (e.g., septate uterus, bicornuate uterus, unicornuate uterus) that significantly alter the endometrial cavity.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Routine Anticoagulant Therapy (Aspirin or Heparin Sodium)
DrugPatients 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Anticoagulant Therapy Cohort1 intervention
Group B: Conventional Treatment Cohort0 interventions
Trial outcomes
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.
Time frame
Up to 90 days of gestationSecondary outcomes
1
Endometrial Thickness
The maximum anteroposterior diameter of the endometrium measured in millimeters (mm) in the midsagittal plane using 2D transvaginal ultrasound.
Time frame
During the window of implantation (prior to embryo transfer)2
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.
Time frame
During the window of implantation (prior to embryo transfer)3
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).
Time frame
During the window of implantation (prior to embryo transfer)4
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.
Time frame
During the window of implantation (prior to embryo transfer)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov