NCT02607319

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

Effect of Low Molecular Weight Heparin (Bemiparin) on Implantation Rate in Patients With Recurrent Implantation Failure Undergoing IVF/ICSI - A Prospective Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: American University of Beirut Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Sterility

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-11-01
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2015-11-18
• Last updated: 2023-07-20

Locations

1 site across 1 country: Lebanon