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

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

Study Description

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 380 participants
• 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

Arms and Interventions

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

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

• 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

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

• 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
• 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:

Abortion, Spontaneous; Pregnancy Complications; Soybean oil, phospholipid emulsion; Fat Emulsions, Intravenous; Parenteral Nutrition Solutions; Pharmaceutical Solutions