Assessment of Intralipid Efficacy in Women With Unexplained Recurrent Implantation Failure

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study will include 100 women with unexplained recurrent implantation failure undergoing IVF/ICSI cycle.

Patients fulfilling the inclusion criteria will be randomised into two groups.

Study Group:

This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of intralipid 20%, on the day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final dose 2-3 weeks later when attending for pregnancy scan.

Control Group:

This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of placebo, on the day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final dose 2-3 weeks later when attending for pregnancy scan.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dar El Teb Institute
• Treatments: Soybean oil, phospholipid emulsion

Criteria

Inclusion Criteria:

• Age 20-38 years of age.

• Repeated implantation failure with 3 or more failed IVF cycles with good quality embryos.

• Normal trans-vaginal ultrasonography.

• Normal hysteroscopy.

• Normal male and female karyotyping.

• Normal anti cardiolipin antibody IGG, IGM and Lupus anticoagulant.

• Normal thrombophilia screen in the form of protein c, s, anti thrombin iii and factor v leiden.

• Written and signed informed consent by the patient to participate in the study.

Exclusion Criteria:

• Age more than 38 years.

• Less than 3 failed IVF cycles.

• Poor embryo quality.

• Expected poor ovarian response.

• Abnormal trans-vaginal ultrasound findings e.g. endometrial polyps or fibroids.

• Abnormal male or female karyotyping.

• Abnormal hysteroscopic finding e.g. endometrial polyps, endometrial hyperplasia, fibroid or congenital anomalies.

• Positive Anticardiolipin antibodies or Lupus anticoagulant.

• Positive thrombophilia screen.

• Allergy to soy oil, eggs, peanut, peanut-based products or any active ingredient in the infusion.

• Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.