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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

Tracking Information
First Submitted Date December 2, 2017
First Posted Date December 7, 2017
Last Update Posted Date December 7, 2017
Estimated Study Start Date December 2017
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 6, 2017)
Clinical pregnancy rate [ Time Frame: until 12 weeks ]
Ongoing pregnancy beyond the 12th gestational week rate
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 6, 2017)
  • Uterine artery blood flow [ Time Frame: luteal phase before ET and one day before ET ]
    by transvaginal sonography
  • Implantation rate [ Time Frame: 8 weeks ]
    by transvaginal sonography
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Anticoagulation Therapies Effect on the Endometrial Blood Flow and Pregnancy Outcomes in Unexplained Recurrent Implantation Failure Women
Official Title Anticoagulation Therapies Effect on the Endometrial Blood Flow and Pregnancy Outcomes in Unexplained Recurrent Implantation Failure Women
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Recurrent Implantation Failure
Intervention
  • Drug: Low dose aspirin
    LDA 25mg tid
  • Drug: Low molecular weight heparin
    LMWH 5000u IH qd
  • Drug: Low dose aspirin plus low molecular weight heparin
    LDA 25mg tid + LMWH 5000u IH qd
  • Drug: no treatment
    Patients who did not receive any treatment.
Study Groups/Cohorts
  • Group A
    Patients who received a daily dose of 75mg LDA per day after menstruation prior to ET.
    Intervention: Drug: Low dose aspirin
  • Group B
    Patients who received a daily dose of 5000u LMWH after menstruation prior to ET.
    Intervention: Drug: Low molecular weight heparin
  • Group C
    Patients who received a daily dose of 75 mg LDA plus 5000u LMWH after menstruation prior to ET.
    Intervention: Drug: Low dose aspirin plus low molecular weight heparin
  • Group D
    Patients who did not receive any treatment.
    Intervention: Drug: no treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: December 6, 2017)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 25 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Shihua Bao, PhD 86-21-20261430 ext 2012 baoshihua@tongji.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03365466
Other Study ID Numbers ShanghaiFMIH-uRIF
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Shihua Bao, Shanghai First Maternity and Infant Hospital
Study Sponsor Shanghai First Maternity and Infant Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Shanghai First Maternity and Infant Hospital
Verification Date September 2017