Intralipid Therapy for Recurrent Implantation Failure and Recurrent Miscarriages: Is it a Hope or Myth?A Randomized Clinical Trial

Overview

Both organ-specific and systemic autoimmunity are associated with an increased prevalence of recurrent miscarriage and reproductive failure, rendering the role of the maternal immunological system in fertility a key concept. It is believed by some that central to this theme is the maternal cytokine profile, with particularly T-helper (Th) cells. Immune modulating therapies have therefore been mooted as potential therapeutic strategies. Recent reports of high pregnancy rates achievable in women with RIF have added fuel to the debate regarding the effectiveness of intralipids in modulating the immune system.

Full Title of Study: “Phase 4 Study of the Efficacy of Intralipid Treatment in Patients With Recurrent Implantation Failure and Miscarriages With High Peripheral and Uterine Natural Killer Cells”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2012

Detailed Description

The investigators would like to assess if that intralipids therapy is an effective treatment for women undergoing repeated failed assisted reproduction cycles and recurrent miscarriages against traditional methods in randomised clinical trial (RCT).

Interventions

  • Drug: intralipid
    • intravenous intralipid 20% is given to the patients known to be have either recurrent failed IVF, RPL

Arms, Groups and Cohorts

  • Experimental: intralipids
    • Two hundreds patients (group1) with abnormal NK activity results (NKa)will receive intralipids 20% i.v. (9 mg/mL total blood volume -corresponds to 2 mL of intralipids 20% diluted in 250 mL saline; or 18 mg/mL – corresponds to 4 mL of intralipids 20% diluted in 250 mL saline) infusions and their NKa will be tested periodically. The determination of NK cell function will be performed by flow cytometry using K562 cells as targets,then follow up of the patients by the Doppler of endometrial blood follow at the time of luteal phase,and the clinical pregnancy rate.Group(2)of 180 patients will receive placebo.

Clinical Trial Outcome Measures

Primary Measures

  • The effectiveness of intralipid on normalization of nk level and rate of clinical pregnancy .
    • Time Frame: 2 ys
    • Two hundreds patients (group1) with abnormal NK activity results (NKa)will receive intralipids 20% i.v. (9 mg/mL total blood volume -corresponds to 2 mL of intralipids 20% diluted in 250 mL saline; or 18 mg/mL – corresponds to 4 mL of intralipid 20% diluted in 250 mL saline) infusions and their NKa will be tested periodically. The determination of NK cell function will be performed by flow cytometry using K562 cells as targets,then follow up of the patients by the Doppler of endometrial blood follow at the time of luteal phase,and the clinical pregnancy rate.Group(2)of 200 patients will receive other routine measures.

Secondary Measures

  • the rate of continuation of pregnancy beyond 12 weeks of pregnancy,the adverse effects related to the drug.
    • Time Frame: 2 ys
    • Two hundreds patients (group1) with abnormal NK activity results (NKa) will receive intralipids 20% i.v. (9 mg/mL total blood volume -corresponds to 2 mL of intralipid 20% diluted in 250 mL saline; or 18 mg/mL – corresponds to 4 mL of intralipid 20% diluted in 250 mL saline) infusions and their NKa were tested periodically. The determination of NK cell function will be performed by flow cytometry using K562 cells as targets,then follow up of the patients by the Doppler of endometrial blood follow at the time of luteal phase,and the clinical pregnancy rate.Group(2)of 200 patients will receive routine measures.

Participating in This Clinical Trial

Inclusion Criteria

1. Recurrent unexplained failed IVF, ICSI.

2. Recurrent unexplained miscarriages.

3. High level of peripheral and uterine NK.

Exclusion Criteria

1. Age above forty years old.

2. Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice).

3. Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).

4. Fibroids distorting uterine cavity.

5. Abnormal parental karyotype.

6. Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).

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: alaa eldeen mahmoud ismail, M D – Woman’s Health University Hospital, Egypt
  • Overall Official(s)
    • Alaa M Ismail, M D, Principal Investigator, Faculty of medicine,Assiut university,Egypt
  • Overall Contact(s)
    • Alaa M Ismail, M D, +201000459514, dr.alaa_ismail@yahoo.com

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