Low Molecular Weight Heparin to Improve Pregnancy Outcome in Patients With Recurrent Implantation Failure (BRIF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02607319|
Recruitment Status : Recruiting
First Posted : November 18, 2015
Last Update Posted : July 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sterility||Drug: Bemiparin sodium||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
Experimental: Low molecular weight heparin
Bemiparin sodium 3,500 IU anti Xa/0.2 ml solution (Hibor; Laboratories Rovi Pharmaceuticals) for injection in pre-filled syringes.
Drug: Bemiparin sodium
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.
Other Name: Hibor
No Intervention: No intervention group
Control group receiving standard care.
- Implantation rate (%) [ Time Frame: Vaginal ultrasound at 8 weeks gestation ]Number of intrauterine gestational sacs observed by transvaginal ultrasonography divided by the number of transferred embryos
- Live birth rate (%) [ Time Frame: Time of delivery up to 42 weeks gestation ]birth of live born
- Ongoing pregnancy rate (%) [ Time Frame: Vaginal ultrasound at 20 weeks of gestation ]Fetal heart beat seen by ultrasound at 20 weeks gestation
- Clinical pregnancy rate (%) [ Time Frame: Vaginal ultrasound at 8 weeks gestation ]Fetal heart beat seen by ultrasound at 8 weeks gestation
- Total pregnancy rate (%) [ Time Frame: Up to 15 days from oocyte collection ]Positive hCG titer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607319
|Contact: Johnny Awwad, MD||00961 1 350000 ext email@example.com|
|Contact: Rola Hammoud, MS||00961 1 350000 ext firstname.lastname@example.org|
|American University of Beirut Medical Center||Recruiting|
|Contact: Johnny Awwad, MD 00961 1 350000 ext 5606 email@example.com|
|Principal Investigator:||Johnny Awwad, MD||AUBMC|