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임상시험 NCT07494877은(는) 불임에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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Effect of Anticoagulant Therapy on Endometrial Receptivity and Pregnancy Outcomes in Infertility 300 관찰 연구

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임상시험 NCT07494877은(는) 불임에 대해 알아보는 관찰연구입니다. 현재 상태는 모집중이며, 연구는 2025년 9월 1일에 시작되어 300명의 참여자를 모집하고 있습니다. Tang-Du Hospital이(가) 진행하며, 2027년 12월 31일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 27일에 갱신되었습니다.
간단한 개요
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...더 보기
상세한 설명
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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공식 제목

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

질환명
불임
기타 연구 식별자
  • K202508-28
NCT 번호
실제 연구 시작일
2025-09-01
최신 업데이트 게시
2026-03-27
예상 연구 완료일
2027-12-31
계획된 등록 인원
300
연구종류
관찰연구
상태
모집중
키워드
Endometrial Receptivity
Anticoagulant Therapy
Multimodal Ultrasound
시험군 / 개입
참가자 그룹/시험군개입/치료
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.
해당 없음
주요결과변수
결과변수측정값 설명시간 범위
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
이차결과변수
결과변수측정값 설명시간 범위
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
참여 도우미
적격성 기준

연령대
성인
최소 연령
20 Years
참여 가능한 성별
여성
  • 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
연구 책임자
zhangli, 책임연구자, Associate Chief Physician, Tang-Du Hospital
연구 대표 연락처
연락처: Li Zhang, MD, 86-29-84778860, [email protected]
연락처: Zhengjun Ma, MM, +86-13072977233, [email protected]
1 1개국에 임상시험 장소

Shaanxi

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