Sterility Clinical Trial
— BRIFOfficial 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
Verified date | July 2023 |
Source | American University of Beirut Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 165 |
Est. completion date | July 2022 |
Est. primary completion date | July 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 38 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Lebanon | American University of Beirut Medical Center | Beirut |
Lead Sponsor | Collaborator |
---|---|
American University of Beirut Medical Center |
Lebanon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Implantation rate (%) | Number of intrauterine gestational sacs observed by transvaginal ultrasonography divided by the number of transferred embryos | Vaginal ultrasound at 8 weeks gestation | |
Secondary | Live birth rate (%) | birth of live born | Time of delivery up to 42 weeks gestation | |
Secondary | Ongoing pregnancy rate (%) | Fetal heart beat seen by ultrasound at 20 weeks gestation | Vaginal ultrasound at 20 weeks of gestation | |
Secondary | Clinical pregnancy rate (%) | Fetal heart beat seen by ultrasound at 8 weeks gestation | Vaginal ultrasound at 8 weeks gestation | |
Secondary | Total pregnancy rate (%) | Positive hCG titer | Up to 15 days from oocyte collection |
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