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

  • STATUS
    Recruiting
  • End date
    Jul 28, 2021
  • participants needed
    200
  • sponsor
    American University of Beirut Medical Center
Updated on 28 January 2021
cavities
semen analysis
hysteroscopy
in vitro fertilization
embryo transfer
intracytoplasmic sperm injection

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.

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.

Details
Condition Female Genital Diseases, Infertility, Gynecological Infections, sterility, unable to conceive
Treatment Bemiparin sodium
Clinical Study IdentifierNCT02607319
SponsorAmerican University of Beirut Medical Center
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 38 yrs?
Are you female?
Do you have Infertility?
Do you have any of these conditions: unable to conceive or Gynecological Infections or sterility or Female Genital Diseases or Infertility?
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)
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