Intralipid for Repeated Implantation Failure

Overview

Intralipid infusion can improve outcome in women with recurrent Intracytoplasmic sperm injection ( ICSI) failure due to elevated TH1 cytokine response.

Full Title of Study: “Does Intralipid Infusion Improve the Implantation Rate in Repeated Implantation Failure: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 2013

Detailed Description

Infertile patients undergoing Intracytoplasmic Sperm Injection (ICSI) cycle with history of repeated implantation failure, intralipid will be given to the intervention group.

The primary outcome measure is the clinical pregnancy rate, secondary outcome measures implantation rate, ongoing pregnancy rate, abortion rate.

Interventions

  • Drug: intralipid
    • IV infusion of intralipid 20% between day4 and 9 of ovarian stimulation & another dose when got pregnant within the 1st week of positive pregnancy test
  • Drug: Saline
    • Saline 0.9% IV infusion between day4 and 9 of ovarian stimulation & another dose when got pregnant within the 1st week of positive pregnancy test

Arms, Groups and Cohorts

  • Placebo Comparator: control
    • Saline 0.9% IV infusion between day 4 and 9 of ovarian stimulation & another dose when got pregnant within the 1st week of positive pregnancy test
  • Experimental: intralipid
    • IV infusion of intralipid 20% between day4 and 9 of ovarian stimulation & another dose when got pregnant within the 1st week of positive pregnancy test

Clinical Trial Outcome Measures

Primary Measures

  • clinical pregnancy rate
    • Time Frame: 10 month
    • pregancy sac with fetal heart activity

Secondary Measures

  • implantation rate
    • Time Frame: 10 month
    • the number of gestational sacs divided by the number of embryos transferred
  • ongoing pregnancy rate
    • Time Frame: 14 month
    • clinical pregnancy continue after 12 weeks gestational age

Participating in This Clinical Trial

Inclusion Criteria

  • Infertile patients undergoing ICSI cycle with history of repeated implantation failure

Exclusion Criteria

1. Disturbances of normal fat metabolism such as pathologic hyperlipemia

2. Allergic to it; or to eggs, soybean oil, or safflower oil.

3. Severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder.

4. Uterine fibroid, endometrial polyp, endometriosis and hydrosalpinx.

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Waleed El-khayat, Assisstant professor – Cairo University
  • Overall Official(s)
    • Waleed El-khayat, M.D., Principal Investigator, Faculty of medicine, Cairo University, Cairo, Egypt

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