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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
165
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.
American University of Beirut Medical Center
Beirut, Lebanon
Implantation rate (%)
Number of intrauterine gestational sacs observed by transvaginal ultrasonography divided by the number of transferred embryos
Time frame: Vaginal ultrasound at 8 weeks gestation
Live birth rate (%)
birth of live born
Time frame: Time of delivery up to 42 weeks gestation
Ongoing pregnancy rate (%)
Fetal heart beat seen by ultrasound at 20 weeks gestation
Time frame: Vaginal ultrasound at 20 weeks of gestation
Clinical pregnancy rate (%)
Fetal heart beat seen by ultrasound at 8 weeks gestation
Time frame: Vaginal ultrasound at 8 weeks gestation
Total pregnancy rate (%)
Positive hCG titer
Time frame: Up to 15 days from oocyte collection
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