Low Molecular Weight Heparin to Improve Pregnancy Outcome in Patients With Recurrent Implantation… (NCT02607319) | Clinical Trial Compass
CompletedPhase 4
Low Molecular Weight Heparin to Improve Pregnancy Outcome in Patients With Recurrent Implantation Failure
Lebanon165 participantsStarted 2015-11
Plain-language 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.
Who can participate
Age range18 Years – 38 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Acu…
What they're measuring
1
Implantation rate (%)
Timeframe: Vaginal ultrasound at 8 weeks gestation
Trial details
NCT IDNCT02607319
SponsorAmerican University of Beirut Medical Center