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

NCT01679561 | Withdrawn Phase 4 DMC

• 1 other identifier: ILRIFRM
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Complicated by Low Implantation

Keywords

implantation failure; recurrent abortion; intralipid

Outcome Measures

Primary Outcomes (1)

• The effectiveness of intralipid on normalization of nk level and rate of clinical pregnancy .

  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.

  2 ys

Secondary Outcomes (1)

• the rate of continuation of pregnancy beyond 12 weeks of pregnancy,the adverse effects related to the drug.

  2 ys

Study Arms (1)

intralipids

EXPERIMENTAL

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

Interventions

intralipid DRUG

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

intralipids

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Recurrent unexplained failed IVF, ICSI.
• Recurrent unexplained miscarriages.
• High level of peripheral and uterine NK.

You may not qualify if:

• Age above forty years old.
• Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies \[IgG or IgM\]); other recognised thrombophilic conditions (testing according to usual clinic practice).
• Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
• Fibroids distorting uterine cavity.
• Abnormal parental karyotype.
• Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).

Sponsors & Collaborators

• Woman's Health University Hospital, Egypt: lead

Study Sites (1)

Women's Health Hospital

Asyut, Egypt

Location

MeSH Terms

Conditions

Abortion, Habitual

Interventions

soybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Alaa M Ismail, M D

  Faculty of medicine,Assiut university,Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M D

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: September 6, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2013
• Last Updated: January 8, 2021

Record last verified: 2021-01

Locations

EG (1)