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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Woman's Health University Hospital, Egypt
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: October 11, 2013
Last verified: October 2013
  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 intralipids 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:


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)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:
  • 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) 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.


Estimated Enrollment: 380
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: intralipid

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).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679561

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

Locations
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
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: October 11, 2013
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
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014