Intralipid Therapy for Women 35-40 Years With Positive Natural Killer Cells Undergoing Intracytoplasmic Sperm Injection (ICSI)

Overview

Intralipid can suppress natural killer cells that are known to be involve in repeated implantation failure and recurrent miscarriages.Intralipid is made of purified soybean oil, egg phospholipids, glycerol and water. It provides essential fatty acids, linoleic acid, omega- 3 and 6 fatty acids and alpha-linolenic acid. The effects of Intralipid in suppressing natural killer cell activity (NKa) were found to be comparable to intravenous immunoglobulin (IVIG) by laboratory experiments.We will study the effect of intralipid infusion on the pregnancy outcome of women aged 35-40 years with history of repeated implantation failure of miscarriage and who have positive peripheral blood natural killer cells

Full Title of Study: “Intravenous Intralipid Therapy Among Women Aged 35-40 Years With Positive Peripheral Blood Natural Killer Cells Undergoing in Vitro Fertilization-Embryo Transfer: A Randomized Controlled Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2015

Interventions

  • Drug: Intralipid infusion
    • IV infusion of 250 ml of intralipid 20% solution at the day of Ovum pick up & another dose at the day of embryo Transfer.

Arms, Groups and Cohorts

  • Active Comparator: Intralipid infusion
    • 100 Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing ICSI cycle.
  • No Intervention: Control group
    • 100 Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing ICSI cycle.

Clinical Trial Outcome Measures

Primary Measures

  • Clinical pregnancy rate
    • Time Frame: 10 months
    • Intrauterine gestational sac with fatal pole and positive pulsation

Secondary Measures

  • Chemical pregnancy
    • Time Frame: 10 months
    • positive pregnancy test (serum BHCG) measured 16 days following embryo transfer
  • implantation rate
    • Time Frame: 10 months
    • the number of gestational sacs divided by the number of embryos transferred
  • ongoing pregnancy rate
    • Time Frame: 10 months
    • clinical pregnancy continue after 12 weeks gestational age
  • Miscarriage rate
    • Time Frame: 12 months
  • Ectopic rate
    • Time Frame: 12 months

Participating in This Clinical Trial

Inclusion Criteria

Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing Intracytoplasmic sperm injection (ICSI ) cycle.

Exclusion Criteria

  • women above 40years or less than 35 years
  • Disturbances of normal fat metabolism such as pathologic hyperlipidemia,Lipoid nephrosis or acute pancreatitis with hyperlipidemia.
  • Allergic to eggs, soybean oil, or safflower oil.
  • Severe liver disease, kidney disease, lung disease, anemia, blood coagulation disorder.
  • Uterine fibroid, endometrial polyp, endometriosis and hydrosalpinx.
  • Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies (Immunoglobulin G or M)[IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice).
  • Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
  • Fibroids distorting uterine cavity.
  • Abnormal parental karyotype.

Gender Eligibility: Female

Minimum Age: 35 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: Eman Elkattan, Dr. – Cairo University

References

Coulam CB, Acacio B. Does immunotherapy for treatment of reproductive failure enhance live births? Am J Reprod Immunol. 2012 Apr;67(4):296-304. doi: 10.1111/j.1600-0897.2012.01111.x. Epub 2012 Feb 16. Review.

Shreeve N, Sadek K. Intralipid therapy for recurrent implantation failure: new hope or false dawn? J Reprod Immunol. 2012 Jan;93(1):38-40. doi: 10.1016/j.jri.2011.11.003. Epub 2011 Dec 21.

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