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