Anticoagulation Therapies Effect on the Endometrial Blood Flow and Pregnancy Outcomes in Unexplained Recurrent Implantation Failure Women
NCT ID: NCT03365466
Last Updated: 2017-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2017-12-31
2019-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group A
Patients who received a daily dose of 75mg LDA per day after menstruation prior to ET.
Low dose aspirin
LDA 25mg tid
Group B
Patients who received a daily dose of 5000u LMWH after menstruation prior to ET.
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.
Low dose aspirin plus low molecular weight heparin
LDA 25mg tid + LMWH 5000u IH qd
Group D
Patients who did not receive any treatment.
no treatment
Patients who did not receive any treatment.
Interventions
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Low dose aspirin
LDA 25mg tid
Low molecular weight heparin
LMWH 5000u IH qd
Low dose aspirin plus low molecular weight heparin
LDA 25mg tid + LMWH 5000u IH qd
no treatment
Patients who did not receive any treatment.
Eligibility Criteria
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Inclusion Criteria
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
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.
25 Years
45 Years
FEMALE
No
Sponsors
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Shanghai First Maternity and Infant Hospital
OTHER
Responsible Party
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Shihua Bao
Principal Investigator
Locations
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Shanghai first Maternity and Infant health hospital, Tong Ji University
Shanghai, , China
Countries
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Central Contacts
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Other Identifiers
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ShanghaiFMIH-uRIF
Identifier Type: -
Identifier Source: org_study_id