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Intralipid Therapy for Recurrent Implantation Failure and Recurrent Miscarriages: Is it a Hope or Myth? (ILRIFRM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier:
NCT01679561
First received: August 20, 2012
Last updated: August 31, 2012
Last verified: August 2012
History of Changes
  Purpose

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 intralipid in modulating the immune system.


Condition Intervention Phase
Pregnancy Complicated by Low Implantation
 Drug: intralipid
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Miscarriage
U.S. FDA Resources

Further study details as provided by Woman's Health University Hospital, Egypt:

Primary Outcome Measures:
  • The effectiveness of intralipid on normalization of nk level and rate of clinical pregnancy . [ Time Frame: 2 ys ] [ Designated as safety issue: Yes ]
    Two hundreds patients (group1) with abnormal NK activity results (NKa) received intralipid 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 was 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.


Secondary Outcome Measures:
  • the rate of continuation of pregnancy beyond 12 weeks of pregnancy,the adverse effects related to the drug. [ Time Frame: 2 ys ] [ Designated as safety issue: Yes ]
    Two hundreds patients (group1) with abnormal NK activity results (NKa) received intralipid 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 was 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.


Enrollment: 380
Study Start Date: February 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intralipid
Two hundreds patients (group1) with abnormal NK activity results (NKa) received intralipid 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 was 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.
 Drug: intralipid
intravenous intralipid 20% is given to the patients known to be have either recurrent failed IVF, RPL
Other Name: intralipid

Detailed Description:

The investigators would like to assess if that intralipid therapy is an effective treatment for women undergoing repeated failed assisted reproduction cycles and recurrent miscarriages

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679561

Locations
Egypt
Women's Health Hospital
Assiut, Egypt
Sponsors and Collaborators
Woman's Health University Hospital, Egypt
Investigators
Principal Investigator: Alaa M Ismail, M D Faculty of medicine,Assiut university,Egypt
  More Information

No publications provided

Responsible Party: alaa eldeen mahmoud ismail, M D, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT01679561     History of Changes
Other Study ID Numbers: ILRIFRM
Study First Received: August 20, 2012
Last Updated: August 31, 2012
Health Authority: United States: Food and Drug Administration
Egypt: Institutional Review Board

Keywords provided by Woman's Health University Hospital, Egypt:
implantation failure
recurrent abortion
intralipid

Additional relevant MeSH terms:
Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications

ClinicalTrials.gov processed this record on May 23, 2013