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

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ClinicalTrials.gov Identifier: NCT01679561
Recruitment Status : Unknown
Verified October 2013 by alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt.
Recruitment status was:  Recruiting
First Posted : September 6, 2012
Last Update Posted : October 16, 2013
Sponsor:
Information provided by (Responsible Party):
alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pregnancy Complicated by Low Implantation Drug: intralipid Phase 4

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2012
Actual Primary Completion Date : August 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: intralipid
intravenous intralipid 20% is given to the patients known to be have either recurrent failed IVF, RPL


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679561


Contacts
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Contact: Alaa M Ismail, M D +201000459514 dr.alaa_ismail@yahoo.com
Contact: Hassan S Kamel hkamehkamel@yahoo.com

Locations
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Egypt
Women's Health Hospital Recruiting
Assiut, Egypt
Contact: Hassan S Kamel, M D       hkamelhkamel@yahoo.com   
Sponsors and Collaborators
Woman's Health University Hospital, Egypt
Investigators
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Principal Investigator: Alaa M Ismail, M D Faculty of medicine,Assiut university,Egypt
More Information
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Responsible Party: alaa eldeen mahmoud ismail, M D, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT01679561    
Other Study ID Numbers: ILRIFRM
First Posted: September 6, 2012    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013
Keywords provided by alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt:
implantation failure
recurrent abortion
intralipid
Additional relevant MeSH terms:
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Abortion, Spontaneous
Pregnancy Complications
Soybean oil, phospholipid emulsion
 Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions