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Anticoagulation Therapies Effect on the Endometrial Blood Flow and Pregnancy Outcomes in Unexplained Recurrent Implantation Failure Women

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ClinicalTrials.gov Identifier: NCT03365466
Recruitment Status : Not yet recruiting
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Shihua Bao, Shanghai First Maternity and Infant Hospital

Brief Summary:
The aim of the study is to investigate whether Low Dose Aspirin and Low Molecular Weight Heparin could increase the uterine perfusion, and finally improve the implantation and pregnancy rates in patients with unexplained recurrent implantation failure.

Condition or disease Intervention/treatment
Recurrent Implantation Failure Drug: Low dose aspirin Drug: Low molecular weight heparin Drug: Low dose aspirin plus low molecular weight heparin Drug: no treatment

Detailed Description:

Infertility is a growing issue for many couples all over the world. Nowadays, Assisted reproductive technology is widely used to treat couples affected by infertility, but, the success rate is still very low. Recurrent implantation failure is an important cause of repeated IVF failure. In addition to the embryo quality, a functioning and receptive endometrium is crucial for embryo implantation. There is a growing amount of evidence shows that uterine perfusion playing an important part in regulating endometrial receptivity and in successful pregnancy.

Recently, transvaginal ultrasonography is often used to examine endometrial thickness, pattern and blood flow status to predict uterine receptivity. Some studies have demonstrated that uterine artery blood flow resistance in RM (Recurrent miscarriage) patients is significantly higher than in normal fertile patients. It has been postulated that abnormal uterine perfusion could be related to the reproductive failure, enhancing the uterine perfusion may improve the successful pregnancy. In accordance with this hypothesis, some therapeutic approaches including low dose aspirin (LDA), nitric oxide donor, low molecular weight heparin, sildenafil are applying in clinic. Low molecular weight heparin (LMWH) is derived from unfractionated heparin. It also has anticoagulation or the antithrombin effect. Aspirin has analgesic, antipyretic, and anti-inflammatory properties. Initially, aspirin and low molecular weight heparin have been used either as single agents or in combination to treat patients with recurrent miscarriage, diagnosed with antiphospholipid syndrome. The treatment confers a significant benefit in live births rate. Furthermore, various studies have shown that thrombophilia are more common in women with RIF compared with healthy fertile controls. In these women, heparin treatment could potentially enhance the implantation process, and may finally improve the live birth rate. The aim of the study is to investigate whether Low Dose Aspirin and Low Molecular Weight Heparin could increase the uterine perfusion, and finally improve the implantation and pregnancy rates in patients with unexplained recurrent implantation failure.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anticoagulation Therapies Effect on the Endometrial Blood Flow and Pregnancy Outcomes in Unexplained Recurrent Implantation Failure Women
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Group/Cohort Intervention/treatment
Group A
Patients who received a daily dose of 75mg LDA per day after menstruation prior to ET.
Drug: Low dose aspirin
LDA 25mg tid

Group B
Patients who received a daily dose of 5000u LMWH after menstruation prior to ET.
Drug: Low molecular weight heparin
LMWH 5000u IH qd

Group C
Patients who received a daily dose of 75 mg LDA plus 5000u LMWH after menstruation prior to ET.
Drug: Low dose aspirin plus low molecular weight heparin
LDA 25mg tid + LMWH 5000u IH qd

Group D
Patients who did not receive any treatment.
Drug: no treatment
Patients who did not receive any treatment.




Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: until 12 weeks ]
    Ongoing pregnancy beyond the 12th gestational week rate


Secondary Outcome Measures :
  1. Uterine artery blood flow [ Time Frame: luteal phase before ET and one day before ET ]
    by transvaginal sonography

  2. Implantation rate [ Time Frame: 8 weeks ]
    by transvaginal sonography



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This is a prospective cohort study on unexplained recurrent implantation failure patients with abnormal uterine perfusion in our clinic from September 2017 to December 2018.
Criteria

Inclusion Criteria:

  1. ≥3 pervious IVF-ET failures or failure with transfer of at least 10 frozen embryos in multiple transfers;
  2. 25-45 years old;
  3. Having a regular menstrual cycle and BBT;
  4. Top-quality frozen embryos for transfer;
  5. Endometrial thickness 8-14mm;
  6. Abnormal uterine perfusion(PI>2.5);
  7. Decided to recieve LMWH or LDA or a combination of LMWH and LDA therapy.

Exclusion Criteria:

  1. Chromosome aberrations in anyone of the couple;
  2. Abnormal uterine cavity;
  3. Hydrosalpinx;
  4. Chronic systemic disease(liver,renal,heart,thyroid and thrombocytopenia)
  5. Having experienced severe allergies, trauma history;
  6. With a history of mental illness;
  7. Any contraindication for LDA or LMWH.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365466


Contacts
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Contact: Shihua Bao, PhD 86-21-20261430 ext 2012 baoshihua@tongji.edu.cn

Locations
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China
Shanghai first Maternity and Infant health hospital, Tong Ji University
Shanghai, China, 200051
Sponsors and Collaborators
Shanghai First Maternity and Infant Hospital

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Responsible Party: Shihua Bao, Principal Investigator, Shanghai First Maternity and Infant Hospital
ClinicalTrials.gov Identifier: NCT03365466     History of Changes
Other Study ID Numbers: ShanghaiFMIH-uRIF
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shihua Bao, Shanghai First Maternity and Infant Hospital:
recurrent implantation failure
aspirin
low molecular weight heparin

Additional relevant MeSH terms:
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Aspirin
Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics