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Low Molecular Weight Heparin to Improve Pregnancy Outcome in Patients With Recurrent Implantation Failure (BRIF)

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ClinicalTrials.gov Identifier: NCT02607319
Recruitment Status : Recruiting
First Posted : November 18, 2015
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Johnny Awwad, American University of Beirut Medical Center

Brief Summary:
The objective of this study is to determine the effect of Bemiparin, a low molecular weight heparin, on implantation rate in women with unexplained recurrent implantation failure undergoing IVF/ICSI treatment.

Condition or disease Intervention/treatment Phase
Sterility Drug: Bemiparin sodium Phase 4

Detailed Description:

Recurrent implantation failure (RIF), defined as failure of conception following three or more consecutive In Vitro Fertilization (IVF) cycles despite the transfer of good quality embryos, is a major cause of distress amongst infertile couples. While factors underlying implantation failure are many, most cases remain unexplained. In order to improve pregnancy outcomes and delivery rates in women with unexplained RIF, various investigational treatments have been proposed.

The investigators propose a prospective controlled randomized comparative study to evaluate the effect of Bemiparin on implantation rates in women with unexplained RIF. A total of 200 patients will be recruited and randomized between two groups. The study group will receive Bemiparin plus standard care; while the control group will receive only standard care. Treatment will start on the day following embryo transfer and will be continued until 12 weeks gestation in the event of pregnancy.

The primary objective is to determine the effect of Bemiparin on implantation rate in women with unexplained recurrent implantation failure.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Low Molecular Weight Heparin (Bemiparin) on Implantation Rate in Patients With Recurrent Implantation Failure Undergoing IVF/ICSI - A Prospective Randomized Clinical Trial
Study Start Date : November 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low molecular weight heparin
Bemiparin sodium 3,500 IU anti Xa/0.2 ml solution (Hibor; Laboratories Rovi Pharmaceuticals) for injection in pre-filled syringes.
Drug: Bemiparin sodium
Bemiparin sodium 3,500 IU will be started on the evening of the same day of embryo transfer and until the day of pregnancy test. If the test is positive, Bemiparin will be discontinued by the end of the 12th week of gestation.
Other Name: Hibor

No Intervention: No intervention group
Control group receiving standard care.



Primary Outcome Measures :
  1. Implantation rate (%) [ Time Frame: Vaginal ultrasound at 8 weeks gestation ]
    Number of intrauterine gestational sacs observed by transvaginal ultrasonography divided by the number of transferred embryos


Secondary Outcome Measures :
  1. Live birth rate (%) [ Time Frame: Time of delivery up to 42 weeks gestation ]
    birth of live born

  2. Ongoing pregnancy rate (%) [ Time Frame: Vaginal ultrasound at 20 weeks of gestation ]
    Fetal heart beat seen by ultrasound at 20 weeks gestation

  3. Clinical pregnancy rate (%) [ Time Frame: Vaginal ultrasound at 8 weeks gestation ]
    Fetal heart beat seen by ultrasound at 8 weeks gestation

  4. Total pregnancy rate (%) [ Time Frame: Up to 15 days from oocyte collection ]
    Positive hCG titer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of three or more consecutively failed In Vitro Fertilization (IVF) cycles after embryo transfer.
  • Normal uterine cavity (as assessed by hysteroscopy or HSG).
  • Normal hormonal investigation: TSH, PRL, FBS.
  • Normal acquired/inherited thrombophilia profile: LAC, ACA IgG/IgM, Prot S, Antithrombin III, beta-2 glycoprotein, Factors V, II, MTHFR.
  • Normal semen analysis and mild/moderate male factor (Total motile sperm count > 5 million/ml and/or normal WHO morphology >20%.
  • Patient provides written informed consent.

Exclusion Criteria:

  • Evidence of low ovarian reserve by at least one of the following: AMH ≤ 1,5 ng/mL and/or basal CD 3 FSH ≥ 10 mIU/mL and/or basal CD 3 Estradiol ≥ 60 ng/mL and/or previous egg collection yield ≤ 3 oocytes.
  • Preexisting medical condition (thyroid disease, diabetes mellitus, hypertension, pulmonary conditions, cardiac condition…).
  • Severe male factor infertility (Total motile sperm count < 5 million/ml and/or normal WHO morphology <20%).
  • Hypersensitivity to Heparin or its derivatives.
  • Acquired thrombophilia.
  • Active hemorrhage or increased risk of bleeding due to impairment of homeostasis.
  • Severe impairment of liver or pancreatic function.
  • Severe renal insufficiency (Creatinine Clearance < 30 ml/min).
  • Injuries to or operations on the central nervous system, eyes and ears within the last 2 months.
  • Disseminated Intravascular Coagulation (DIC) attributable to heparin-induced thrombocytopenia.
  • Acute bacterial endocarditis and endocarditis lenta.
  • Any organic lesion with high risk of bleeding (e.g.: active peptic ulcer, hemorrhagic stroke, cerebral aneurysm or cerebral neoplasms).

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): NCT02607319


Contacts
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Contact: Johnny Awwad, MD 00961 1 350000 ext 5606 jawwad@aub.edu.lb
Contact: Rola Hammoud, MS 00961 1 350000 ext 5606 ruh00@aub.edu.lb

Locations
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Lebanon
American University of Beirut Medical Center Recruiting
Beirut, Lebanon
Contact: Johnny Awwad, MD    00961 1 350000 ext 5606    jawwad@aub.edu.lb   
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
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Principal Investigator: Johnny Awwad, MD AUBMC

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Responsible Party: Johnny Awwad, Professor of Obstetrics and Gynecology, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT02607319     History of Changes
Other Study ID Numbers: AmericanUBMCRIF
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johnny Awwad, American University of Beirut Medical Center:
Recurrent Implantation Failure
Implantation
low molecular weight heparin
In vitro Fertilization
Assisted Reproductive Technology
Pregnancy
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Dalteparin
Bemiparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action