NCT02861105

The Effect of LMWH on ICSI in Patients With Unexplained Infertility and Negative Immunological Markers

The Effect of LMWH on ICSI Outcome in Patients With Unexplained Infertility and Negative Immunological Markers; a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 716 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 38 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy of LMWH treatment in women with unexplained infertility and negative immunological markers undergoing ICSI.

Detailed description

Inclusion criteria: 1. patients undergoing 1st trial ICSI 2. unexplained infertility 3. negative immunological markers including ACL abs, LAC, ANA, ATA, AnitdsDNA Exclusion criteria: 1. previous IVF/ICSI 2. Any cause of infertility 3. Suspected and/or unexpected poor response during ovulation induction 4. positive immunological markers 5. Age \> 40 years. All participants will undergo IVF/ICSI cycle using the Long luteal phase protocol. the dose of gonadotropins will be calculated according to patient age and BMI. All patients will have 2-3 embryos transferred at D5 according to their age. the primary outcome will be LBR. secondary outcomes will include biochemical pregnancy rate and clinical pregnancy rate.

Conditions

• Unexplained Infertility

Interventions

Type	Name	Description
DRUG	LMWH	LMWH will be given on daily basis subcutaneously every 24 hours starting one day after ovum pick up till documentation of fetal life by ultrasound at 7 weeks.
OTHER	0.9% saline solution	0.9% saline solution will be given subcutaneously every 24 hours starting one day after ovum pick up till documentation of fetal life by ultrasound at 7 weeks.

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-01-01
• Completion: 2016-03-01
• First posted: 2016-08-10
• Last updated: 2016-08-12