Effect of Low Molecular Weight Heparin administration on ICSI outcome in patients with Unexplained Infertility and Negative Immunological Markers: A Randomized Controlled Trial

Abstract

Unexplained infertility is defined as failure to conceive after one year in couples with normal semen samples and no abnormality found during an infertility workup (Harrison and Taylor, 2006) The principal treatments for unexplained infertility include: expectant management, clomiphine citrate, intrauterine insemination alone or with controlled ovarian stimulation and IVF (Pandian et al., 2012) However, according to the National Institute for Health and Care Excellence (NICE) guidelines, IVF is the recommended treatment to women with unexplained infertility who have not conceived after 2 years of regular unprotected sexual intercourse (NICE, 2013) In light of the possible effects of heparins and heparin binding molecules on the blastocyst implantation and placentation, we conducted this study in order to assess the efficacy of LMWH in improving the pregnancy rates in women with unexplained infertility and negative immunological markers undergoing ICSI. A randomized controlled trial was carried out on 680 women undergoing ICSI with negative immunological markers, 340 of which were randomly allocated to the group that receives LMWH after ovum pick-up and continues to receive it until documentation of fetal life by ultrasound at 7 weeks of gestation and 340 women were allocated to the group that receives placebo.