Intralipid Therapy for Recurrent Implantation Failure and Recurrent Miscarriages: Is it a Hope or Myth?A Randomized Clinical Trial (ILRIFRM)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01679561 |
Recruitment Status :
Withdrawn
First Posted : September 6, 2012
Last Update Posted : January 8, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pregnancy Complicated by Low Implantation | Drug: intralipid | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
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 |
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 |
- 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.
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Recurrent unexplained failed IVF, ICSI.
- Recurrent unexplained miscarriages.
- High level of peripheral and uterine NK.
Exclusion Criteria:
- 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).

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
Egypt | |
Women's Health Hospital | |
Assiut, Egypt |
Principal Investigator: | Alaa M Ismail, M D | Faculty of medicine,Assiut university,Egypt |
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: | January 8, 2021 |
Last Verified: | January 2021 |
implantation failure recurrent abortion intralipid |
Abortion, Spontaneous Pregnancy Complications Soybean oil, phospholipid emulsion |
Fat Emulsions, Intravenous Parenteral Nutrition Solutions Pharmaceutical Solutions |