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Lo studio clinico NCT07494877 per Infertilità è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Effect of Anticoagulant Therapy on Endometrial Receptivity and Pregnancy Outcomes in Infertility 300 Osservazionale

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07494877 è uno studio osservazionale per Infertilità, attualmente in arruolamento. Avviato il 1 settembre 2025, prevede di arruolare 300 partecipanti. Sotto la guida di Tang-Du Hospital, dovrebbe concludersi entro il 31 dicembre 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 27 marzo 2026.
Sommario breve
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 appr...Mostra di più
Descrizione dettagliata
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 loc...

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Titolo ufficiale

Evaluation of the Effect of Anticoagulant Therapy on Endometrial Receptivity and Pregnancy Outcomes in Patients With Infertility Using an Ultrasound Multimodal System

Patologie
Infertilità
Altri ID dello studio
  • K202508-28
Numero NCT
Data di inizio (effettiva)
2025-09-01
Ultimo aggiornamento pubblicato
2026-03-27
Data di completamento (stimata)
2027-12-31
Arruolamento (previsto)
300
Tipo di studio
Osservazionale
Stato
In arruolamento
Parole chiave
Endometrial Receptivity
Anticoagulant Therapy
Multimodal Ultrasound
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
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.D.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto
Età minima
20 Years
Sessi idonei
Femmina
  • 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 Hospital logoTang-Du Hospital
Parte responsabile dello studio
zhangli, Investigatore principale, Associate Chief Physician, Tang-Du Hospital
Contatti principali dello studio
Contatto: Li Zhang, MD, 86-29-84778860, [email protected]
Contatto: Zhengjun Ma, MM, +86-13072977233, [email protected]
1 Centri dello studio in 1 paesi

Shaanxi

Tangdu Hospital, Air Force Medical University, Xi'an, Shaanxi, 710038, China
Li Zhang, MM, Contatto, 86-29-84778860, [email protected]
Zhengjun Ma, MM, Contatto, +86-13072977233, [email protected]
In arruolamento