Intralipid for Recurrent Miscarriage

Overview

Intralipid infusion can improve the outcome in NK cells positive females with history of recurrent miscarriages undergoing IVF/ICSI cycles.

Full Title of Study: “The Role of Intralipid in Natural Killer Cell Positive Cases With Recurrent Miscarriages Undergoing IVF/ICSI Cycles: a Double Blind 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: August 2016

Interventions

  • Drug: Intralipid
    • IV infusion of intralipid 20% is administrated on the day of vaginal egg collection in a dose of 9 mg/ml total blood volume corresponding to intralipid 2 ml 20% diluted in 250 ml saline over 30-60 minutes.the intralipid infusion is then repeated within the 1st week of positive pregnancy test and every 2 weeks till end of first trimester

Arms, Groups and Cohorts

  • Experimental: Intralipid
    • IV infusion of intralipid 20% is administrated on the day of vaginal egg collection in a dose of 9 mg/ml total blood volume corresponding to intralipid 2 ml 20% diluted in 250 ml saline over 30-60 minutes. the intralipid infusion is then repeated within the one week of positive pregnancy test and every 2 weeks till end of first trimester
  • No Intervention: Control
    • No intervention

Clinical Trial Outcome Measures

Primary Measures

  • chemical pregnancy rate
    • Time Frame: 10 months
    • Positive pregnancy test in blood as measured by quantitative B- hCG level

Secondary Measures

  • clinical pregnancy rate,
    • Time Frame: 10 months
    • Confirmed pregnancy at 7 weeks by ultrasound visualization of gestational sac and positive fetal pulsations

Participating in This Clinical Trial

Inclusion Criteria

  • Couples with unexplained secondary infertility
  • Three or more prior consecutive clinical miscarriages after either spontaneous pregnancy or after IVF/ICSI.
  • Elevated natural killer (NK) cells CD16, CD56 and cells with both CD16/CD56 >12%.

Exclusion Criteria

  • Age above forty years old.
  • Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice).
  • Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
  • Abnormal parental karyotype.
  • Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).
  • Disturbances of normal fat metabolism such as pathologic hyperlipemia
  • Allergic to it; or to eggs, soybean oil, or safflower oil.
  • Severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Woman’s Health University Hospital, Egypt
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dina Mohamed Refaat Dakhly, M.D. – Woman’s Health University Hospital, Egypt
  • Overall Official(s)
    • Dina M Dakhly, M.D., Principal Investigator, Cairo University

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