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Effect of LMWH on Pregnancy Outcome in Women With Multiple Failures of IVF-ET

NCT03701750 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2020-07-29

No results posted yet for this study

Summary

Low-Molecular-Weight-Heparin (LMWH) has been used empirically in patients undergoing in-vitro fertilization embryo transfer (IVF-ET) with the purpose to aid in improving pregnancy outcomes. The potential mechanism is that LMWH could exert its anticoagulant effect by inhibiting factor Xa, reducing the risk of insufficiency blood supply in the very early stage of pregnancy. Moreover, LMWH is supposed to play a role in manipulating blastocyst supposition, adhesion, and implantation, as well as trophoblast differentiation and invasion. However, limited high-quality clinical trials focus on the effectivity of LMWH in IVF-ET, and the published evidence is not consensus, leading to considerable controversy in the clinical application of LMWH in IVF-ET patients. Here, investigators try to evaluate the effect of LMWH on pregnancy outcome in women with multiple failures of IVF-ET via a multi-center randomized controlled trial.

Conditions

Interventions

DRUG

Low Molecular Weight Heparin (enoxaparin sodium)

enoxaparin sodium 40mg/day subcutaneously after oocyte collection, and routine luteal phase support after embryo transfer until clinical pregnancy confirmed by ultrasound

Sponsors & Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    collaborator OTHER

  • Renmin Hospital of Wuhan University

    collaborator OTHER

  • Shenzhen Zhongshan Urology Hospital

    lead OTHER_GOV

Principal Investigators

  • Haixiang Sun, M.D. Ph.D · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  • Jing Yang, M.D. Ph.D · Renmin Hospital of Wuhan University

  • Ruochun Lian, M.D. Ph.D · Shenzhen Zhongshan Urology Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2021-10-31
Completion
2022-10-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03701750 on ClinicalTrials.gov