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

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American University of Beirut Medical Center
• Treatments: Bemiparin; Calcium heparin; Dalteparin; Heparin; Heparin, Low-Molecular-Weight

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).