CAREFertility Forum Index FAQ Search Watched Topics Login
Register

CAREFertility Forum Index » General Forum » INTRALIPIDS All you need to know!!!!!!!!
Post new topic  Reply to topic FAQ  
 
Choice4
Joined: 21 Sep 2008
Posts: 180
PostPosted: Sat Jan 24, 2009 9:54 pm

Intralipids

Information gathered from Immunologysupport group discussions
http://groups.yahoo.com/group/immunologysupport/

Updated 1/7/09

Contents:

I. What is Intralipid?
II. Dosage and administration
III. Cost
IV. Where can I obtain Intralipid for Reproductive Issues?
V. The patient trial in progress
VI. Intralipid FAQs answered by Dr Coulam
VII. Patient experiences
VIII. Studies


I. What is Intralipid?

Taken from:

http://www.illinoisivf.com/recurrent-pregnancy-loss/pre-implantation.html

Evidence from both animal and human studies suggest that intralipid administered intravenously may enhance implantation. Intralipid is a 20% intravenous fat emulsion used routinely as a source of fat and calories for patients requiring parental nutrition. It is composed of 10% soybean oil, 1.2% egg yolk phospholipids, 2.25% gylcerine and water. Intralipid stimulated the immune system to remove “danger signals” that can lead to pregnancy loss. The appeal of Intralipid lies in the fact that it is relatively inexpensive and is not a blood product.
Also see Intralipid article taken from the SIRM discussion board:
http://forums.haveababy.com/index.php?act=announce&f=10&id=48
INTRALIPID 20% – FINALLY AN EFFECTIVE, SAFE AND LOW COST ALTERNATIVE TO IVIG THERAPY.

It is no secret that SIRM has long advocated aggressive treatment of immunologic implantation dysfunction in women undergoing IVF. In cases where there has been Natural Killer Cell activation (Nka) (as evidenced by an abnormal K562 target cell test) we have championed the use of IVIG to down regulate (deactivate) the Nka. In this manner, many women who otherwise might not have achieved success with IVF have gone from infertility to family.

For us at SIRM , advocating the use of IVIG over the last decade, has come at a considerable price. Clearly, women requiring IVIG have been concerned about the cost (more than $4000 per dosage), reported side effects and, given the HIV/hepatitis scare, have been reluctant to receive a blood product. To make matters worse, under-informed critics have for unexplained reasons played on such unfounded fear often raising it to the level of alarm. The fact is that over the years we have administered IVIG to thousands of women, without a single report of viral transmission and few significant (but always transient) side effects.

About a year ago reports began to surface regarding a low cost (about ten times less than IVIG) synthetic product called Intralipid, which upon being infused more than a week prior to embryo transfer would lower Nka and further more, was virtually free of side effects.

About a year ago, we began evaluating the effect of Intralipid in patients who had activated Natural Killer cells, and for whom IVIG therapy would otherwise be indicated. Thus far we have treated more than 30 women with Nka using Intralipid 20%. More than 60% of the patients achieved viable ongoing pregnancies, showing Intralipid therapy to be at least as effective (and perhaps even more so) than IVIG. There were no significant side effects and patient tolerance of this treatment was high. We anticipate that patients receiving Intralipid will soon start reporting on their experience using Intralipid, on various discussion boards.

Against this background, SIRM physicians have collectively decided to virtually abandon further use of IVIG, in favor of Intralipid.

If you have any questions about Intralipid therapy , please don’t hesitate to contact an SIRM physician for more information.

Below are some clinical details about Intralipid:

INTRALIPID INFUSION: A SAFE AND INEXPENSIVE ALTERNATIVE TO IVIG FOR IMPLANTATION DYSFUNCTION:
Geoffrey Sher MD

Intralipid (IL), is a synthetic product composed of 10% soybean oil, 1,2% egg yolk phospholipids, 2.25% glycerin and water. Based on research performed at SIRM and elsewhere, infusion of IL lowers Natural Killer cell activation (Nka) as effectively as does, intravenous gammaglobulin (IVIG.) When indicated IL (as with IVIG) is infused 7-10 days prior to ET and one more time again after a positive pregnancy in women whose Nka is due to an autoimmune causes (antiphospholipid antibodies and/or antithyroid antibodies). In cases of alloimmune implantation dysfunction (DQa and/ HLA matching between the embryo recipient and the male partner) the same applies but in this situation the infusion is repeated at 2-4 week intervals until the 24th week of pregnancy.
We have supplanted IVIG with IL therapy in a significant number of women undergoing IVF , and who had immunologic embryo implantation dysfunction. The results thus far have been excellent, way beyond our initial expectations.
At last we now have a safe and inexpensive alternative to IVIG therapy…Intralipid! What is more, IL costs about 10 times less than IVIG, is not a blood product and is without significant side effects.
//////////////////////////////////
For the present, IVIG must still be regarded as the mainstay of treatment.

II. Dosage and Administration
(Based on its designed treatment for fatty acid deficiency)

Taken from:

http://www.rxmed.com/b.main/b2.pharmaceutical/b2.1.monographs/CPS-%20Monographs/CPS-%20%28General%20Monographs-%20I%29/INTRALIPID.html

Prevention of Essential Fatty Acid Deficiency: The recommended minimum requirement is approximately 4% of the caloric intake. In most patients, this can be supplied as 500 mL of Intralipid 10% administered i.v. twice weekly.

Adults: Dosage should normally not exceed 2 g of fat/kg body weight/day (20 mL, 10 mL and 6.7 mL/kg of Intralipid 10%, 20% and 30%, respectively). In raised energy requirements, the supply of Intralipid can be increased but should not, without special precautions, exceed a quantity corresponding to 3 g fat (30 mL, 15 mL and 10 mL of Intralipid 10%, 20% and 30%, respectively)/kg body weight/day.

The drip rate is adjusted to about 2 to 3 mL/minute for Intralipid 10% and about 1 to 2 mL/minute of Intralipid 20% at which rates 500 mL can be infused in 3 to 5 hours and 5 to 9 hours, respectively. The infusion time for 500 mL must not be shorter than 3 and 5 hours, respectively. The infusion should be started at half the infusion rate during the first 30 minutes, under supervision.

A daily supplement of 333 mL of Intralipid 30% (100 g fat) is regarded as sufficient to meet the basal metabolic requirements of a 70 kg patient on total parenteral nutrition. The drip rate is adjusted to 0.6 to 1 mL/minute at which rate 333 mL can be infused over a period of 5 to 10 hours. The rate of infusion should not exceed 333 mL of Intralipid 30% over a 5-hour period. The infusion should be started at half the infusion rate during the first 30 minutes, under supervision.

IVF protocol used by SIRM as of 11/08:
100ml Intralipid dissolved in 500cc of normal saline 7-14 days prior to ET and repeated with a positive pregnancy test beta then administered every month until the 20th week.

Availability And Storage: Intralipid 10%: 1 000 mL contain: purified soybean oil 100 g, purified egg phospholipids 12 g, glycerol anhydrous 22 g, water for injection q.s. ad 1 000 mL. pH is adjusted with sodium hydroxide to pH approximately 8. Energy content/L: 4.6 MJ (1 100 kcal). Osmolality (approx.): 300 mOsm/kg water. Bottles of 500 mL.

Intralipid 20%: 1 000 mL contain: purified soybean oil 200 g, purified egg phospholipids 12 g, glycerol anhydrous 22 g, water for injection q.s. ad 1 000 mL. pH is adjusted with sodium hydroxide to pH approximately 8. Energy content/L: 8.4 MJ (2 000 kcal). Osmolality (approx.): 350 mOsm/kg water. Bottles of 100, 250 and 500 mL.

Intralipid 30%: 1 000 mL contain: purified soybean oil 300 g, purified egg phospholipids 12 g, glycerol anhydrous 16.7 g, water for injection q.s. ad 1 000 mL. pH is adjusted with sodium hyroxide to pH approximately 7.5. Energy content/L: 12.6 MJ (3 000 kcal). Osmolality (approx.): 310 mOsm/kg water. Bottles of 333 mL.

Store at controlled room temperature below 25°C. Do not freeze.

III. Cost

As of July 2006 the price of intralipid therapy was reported to be $350 for consult with Dr Coulam, $400 for the infusion for the first hour, $160/hr after that.
Cost of Intralipids has been reported to be about $100 a dose.

IV. Where can I obtain Intralipid for Reproductive Issues?


The clinic:
Carolyn B. Coulam, M.D. (in the US)
Rinehart Center for Reproductive Medicine.
233 E Erie, Suite 500
Chicago, IL 60611
Phone: (312) 944-2600
Fax: (312) 944-0100
E-mail: pregnancysuccess@aol.com or cbcoulam@aol.com
Website: http://www.illinoisivf.com/index.html.
Discussion boards: http://www.inciid.org/forums/immune/index.html
http://www.inciid.org/forums/miscarriage/index.html

Brian Acacio, M.D. (in the US)
Acacio Fertility Center
Laguna Niguel
Southern California
Ph (949)249-9200 |
email: care@acaciofertility.com
URL: http://www.acaciofertility.com/

Jerome Check M.D. (in the US)
Cooper Center
8002 E. Greentree Commons
Marlton, NJ 08053
Phone: 609-751-5575
URL: http://www.ccivf.com/
Patient comments: “Dr. Jerome Check in Marlton, NJ will be offering Intralipid treatment beginning in June 2008. For the time being he's only charging $300 for each infusion (one hour). There are no additional consult fees or fees for the Rx itself. But it's so new that the nurse told me that could change”

Paul Armstrong, M.D. (in the UK)
The Portland Hospital
205-209 Great Portland street
London W1W 5AH England
0207-580-4400 (Speak to Paulette his secretary)
- OR -
Royal London Hospital
Whitechapel London E1 1BB England
ph 0207-377-7000 ex 2579
Ph (Speak to Anne, his secretary) 171-377-7000 ext. 2579
Patient comments: “Dr Armstrong at the portland hospital is now also prescribing
intralipids for immune treatment. He is happy to give you a prescription if you want to buy it yourself from healthcare at home, or he can arrange it.”

Dr. Amin Gorgy (in the UK)
Fertility &Gynaecology Academy
140 Harley St. London W1, UK
Telephone: 0207-224-1880
URL: http://www.fertility-academy.co.uk/
Patient comments: “Dr Gorgy is starting to use intralipid apparently.”


Dr George Ndukwe (in the UK)
CARE at The Park Hospital
Sherwood Lodge Drive
Arnold
Nottingham NG5 8RX
Tel: +44(0)115 9671670
Fax: +44(0)115 9673542
Email: George.Ndukwe@care-ivf.com
Ellie ellie.boulton@care-ivf.com (Dr Ndukwe’s assistant. She responds more promptly to emails)
Website: http://www.carefertilityweb.co.uk/
Discussion board: http://194.72.47.117/cgi-bin/ubbcgi/ultimatebb.cgi?ubb=forum;f=11



Pharmacies that offer Intralipids:

1. Columbia pharmacy (in the US)
(312)791-3334
Intralipids 20% in 100ml: $100

2. MDR pharmacy (in the US)
(818)501-7000
Intralipids 20% in 100ml: $70

3. Healthcare at Home (in the UK)
Tel: 08706001540
http://www.healthcare-at-home.com/Default.aspx?pageId=125
“Ask to speak to Claire. Cost £350 for the drug including the nurse coming to give
you the infusion at home. She requires a prescription from a UK doctor with the instructions.”

V. The patient trial in progress

Dr Coulam’s words taken from:
http://www.inciid.org/cgi-brd/getmsg.pl/38/6640

Re: intralipids and nk cells

Posted by Carolyn Coulam MD on 10:27 4/27/2006:
This is current work in progress. We have laboratory data that
intralipid is as effective as IVIg is suppressing NK cell killing
activity. We are currently testing the notion that it does the same
in patients. If anyone is interested in participating in the study,
they may call 312 944 2600 to make an appointment for consultation
to determine eligibility for the study.
Dr. Coulam



One patient’s post about the study:

Dr. Coulam is doing a study on intralipids.

There's no funding for this study so if you want to see if it will
work for you, you need to call Dr. Coulam's office and schedule a
phone consult.

Phone consults are done after she receives your paperwork and copies
of pertinent medical records (ie, history of IVIg dosages and most
records from Rosalind Franklin: NKs, Cytokines, etc).

Consults are $350 and then you're on your own for the fee for
intralipids and the infusion. I think her office works with Blue
Cross and a few other insurance companies, but because this is a
study, reimburesment might not be possible. It's not a huge fee when
you consider what we're paying for IVIg and consults with DS.

If Dr. Coulam can demonstrate that intralipids work as well as IVIg,
it will be a boon to all of us. Intralipids cost less than $100 +
infusion fees whereas IVIg can be $1400 and up.

I signed up and my phone consult. I hope some of you
will sign up as well!


VI. Intralipid FAQs answered by Dr Coulam, Jan 2007
Taken from her discussion board:
http://www.inciid.org/forums/immune/index.html


Question: Why is it that some people can't get their levels below 10% with IVIG or intralipids?
Dr Coulam: Because their NK cells are so activated that they don’t suppress with the usual doses of medication. These results indicate that you would need an increased dose of either medicine.
Question: Even though intralipids are still in research stage for treatment of NK cells, would it make sense to treat my case with intralipids rather than IVIG, since neither got them to normal range, but intralipids got them lower, and would save considerable money?
Dr Coulam: Whether intralipid therapy is indicated for you would depend, not only on your lab results, but also the results of other laboratory tests and you medical history.
Question: Can one conceive with levels at 11-12% if that is the best I can get?
Dr Coulam: Yes, conception is possible.
Question: Is 16.9% dangerously high, or do you see higher?
Dr Coulam: 16.9% is moderately high
Question: Can my NK cells be higher after a failed IVF? If so, generally how long is recommended for them to normalize?
Dr Coulam: Elevated NK cells are usually the cause rather than the result of failed IVF.
Question: If one is getting sick (cold or viral infection) at beginning of IVF cycle, would it be prudent to cancel cycle for fear of NK cells being too high at transfer time? Or would uterine NK cells not be affected by cold?
Dr Coulam: NK cells are affected by viral infections.
Question: Would combining IVIG and Intralipids possibly get levels lower than the 11-12 % that was independently achieved with each sort of treatment?
Dr Coulam: Occassionally we combine the two medications if the higher doses of each do not work.
Question: How soon in advance of transfer is optimally recommended for intralipids infusion? How often should they be done? (any idea of their life?)
Dr Coulam: One week. Half life appears to be between 2 and 4 weeks at this time.
Question: What's the protocol for Intralipid IV? I have had it twice with different doctors and the first time it took 2 hours and the second time only 30 minutes. I developed pretty bad body aches and kind of flu like symptoms several days after the second (fast) treatment. Could it be related to the treatment?
Dr Coulam: We usually infuse it within 30 minutes. The flu like symptoms you experienced several days after the infusion were not related to the intralipid as we would expect any side effects to be immediate.
Question: What is the Intralipid protocol in an IVF cycle?
Dr Coulam: Depending on the specific situation, we usually give the first infusion of intralipid during stiumlation with gonaotropin and the second infusion with the first positive pregnancy test. We usually start lovenox with the first positive pregnancy test.


VII. Intralipid experiences

2/24/07: “I just found out today when i went in for my 1st beta that the nk test result from tx day went down only 0.7, they were 11.7 and are now 11. I did Intralipids 2 days before ER and had a 3 day tx.Today is my 1st beta day and i wont know the results till the 2nd test on Thurs.
Well my concern is...if it only went down .7 which means its still elevated would this prevent me from getting pg?? When i asked the nurse, she said they are more concerned about keeping the pgcy going.?!?!?My nurse kept saying, incase i get pg i would need another dose, so shouldnt i get the results right away and start another dose just incase im pg?
This is the 1st time ive taken intralipids so dont know how they work and what the process is.
My hx- got pg after 3 tries in 2004 on a fresh IVF 4blast tx.
1 failed ivf in Sept tx 4blasts. currently 2ww on fresh ivf tx 4 embies. (did intralipids, taking heparin and ASA)”

5/24/07: “Hi, I'm new here and 9 weeks pregnant. Prior to becoming pregnant, my
only elevated result (through Millenova) was CD19+56 at 12.6. This
went up to 17.5 upon becoming pregnant, and fell to 15.5 and 13.5
after one dose of intralipids. I then had a second dose of
intralipids, but don't have the latest result.”

7/18/07: “I am about to do an IVF cycle using Intralipids instead of IVIg. This
is through Dr. Acacio with SIRM in Orange County, CA
(www.haveababy.com). The pioneer of this alternative is Dr. Coulum in
Chicago (Dr. Acacio has collaborated with her and published some of
their research). Although it's still experimental, it looks very
promising and seems to work just as well as IVIg. The best part is
that it is REALLY cheap (under 100$ for an IV infusion as opposed to
2000-3000$ per infusion with IVIg). The main difficulty is finding
someone who will prescribe it for you. I am very lucky that I happen
to live a few miles away from Acacio's clinic. I know both he and Dr.
Coulum see patients from out of state and out of the country, so it
might be worth contacting them. In any case, I wish you the very best
luck with your next cycle!”

12/18/07: “Dr. Coulam doesn't push intralipids. It is a clinical trial. When I first found out I was going to need IVig, I wondered if there was another alternative because I did not want to do IVig both for the cost and because it's a blood product, bad side effects, etc. It just kind of scared me.
So someone on here told me about intralipids (thank you!). Dr. Coulam did a NK assay and found that both IVig and intralipids suppressed my killer cells.
So as of Jan 1 we are going to be switching to HMO IL which covers IVF up to 4 times (we live in WI). So I went to Dr. Coulam to see if she would do IVF with intralipids the beginning of Jan. and she agreed to do it.
Well just a couple weeks after that, we found out we are pregnant (almost 6 weeks now). It is an absolute MIRACLE as we had been trying 2 1/2 yrs, had several failed IUIs, a couple failed IVF cycles, my husband also has low morphology, I have a killer cell problem, we didn't think there would be ANY chance of ever conceiving on our own. So when pregnancy was confirmed, I went to Dr. Coulam and she administered the intralipids.
Sorry for the long story. Here is what she explained as the difference between intralipids/IVig. IVig as you know is derived from blood, it takes 2-4 hours or so to administer, it is quite costly and there are not so good short term side effects.
Intralipids is a man-made product (I believe it's soybean oil and some other things like that), it only took 40 min. to administer, I didn't have any side effects, it cost $600 and lasts for about a month. And so far, knock on lots of wood, I'm still pregnant.
I hope that helps!”

10/1/08: “I realize I haven't had nearly as much trouble as a lot of people on this site, but will share a short version of my story. We tried for 2 1/2 years to get pregnant, 4 IUI's, 2 IVF cycles, nothing worked. My doctor said I had high killer cells and would need IVIg. I looked for alternatives and found Dr. Coulam in Chicago and contacted her about intralipids instead. We were going to start an IVF/intralipid cycle Jan 2008, however in November 07, I discovered I was pregnant all on my own! The ONLY thing that changed was that in the cycle right before, I had 3 wisdom teeth pulled. I had put off getting them out for 7 years and there were pretty badly decayed. Once we found out we were pregnant, I went to see Dr. Coulam. Due to my history of elevated NK cells, she gave me one dose of intralipids and then I saw her weekly thru 12 weeks of pregnancy for an ultrasound and blood work (I then continued sending her my blood thru 7 mos to check killer cells). Not once thru my entire pregnancy were they high! I gave birth to a happy, healthy baby boy on August 11, 2008.
I swear my killer cells were high due to my body trying to fight off the infection caused by my teeth, sounds crazy, but I truly believe it!
Though I didn't end up doing an IVF cycle with Dr. Coulam, I have nothing but good things to say about her and the nurses at the Reinhart Center!!”


VIII. Intralipid Studies


***********************
1. Am J Reprod Immunol. 1994 Dec;32(4):290-3.

Intralipid as treatment for recurrent unexplained abortion?

Clark DA.

Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

PROBLEM: Safe, effective, and inexpensive alternatives to partner leukocyte immunotherapy are being sought. Psychotherapy may be effective but it is uncertain what constitutes effective treatment and the form of treatment tested in cohort controlled trials is expensive. IVIG also appears effective, but is expensive. METHOD: A published double blind randomized controlled trial in which Intralipid (Kabi Vitrum, Toronto, Ontario) was used as a control versus trophoblast membrane vesicles was reviewed. A prediction made from this data was then tested using the DBA/2-mated CBA/J mouse model of recurrent spontaneous abortion. RESULTS: It can be hypothesized from the human clinical trial data that Intralipid even in small doses could be an effective antiabortion treatment. The number of patients in the published study is too small for the required degree of precision. Intralipid was highly effective in preventing abortion in mice, and protection was prolonged. This may be explained by previous data in the literature showing that Intralipid affects the reticuloendothelial system of the recipient. CONCLUSIONS: The evidence suggests that Intralipid might be an effective treatment for human recurrent miscarriages, and injection into women who may become pregnant has been found ethically acceptable at one university center. Comparison of Intralipid to partner leukocyte immunotherapy or IVIG would be worthwhile. For adequate statistical power, this would require a large, multicenter, prognostically stratified randomized controlled trial and could be accomplished via the Recurrent Miscarriage Immunotherapy Trialists Group network.

PMID: 7718096 [PubMed - indexed for MEDLINE]
****************
2. J Reprod Immunol. 1993 May;24(1):29-44.
Effect of prostaglandin synthesis inhibitors on spontaneous and endotoxin-induced abortion in mice.

Clark DA, Banwatt D, Chaouat G.

Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

The putative role of prostaglandin E2 (PGE2) in suppressing rejection of the 'fetal allograft' (resorption) in C3H/HeJ and CBA/J allopregnant mice was tested by administration of the prostaglandin synthesis inhibitors indomethacin (INDO) and acetylsalicylic acid (ASA). When the resorption rate was low, INDO fed at a dose of 15 micrograms/ml in drinking water after implantation had a slight augmenting effect when the endogenous resorption rate was < 30%, but had no effect when the endogenous rate was higher or when bacterial lipopolysaccharide (LPS) was given. ASA fed at 50 micrograms/ml had no augmenting effect and did not increase sensitivity to the abortogen LPS in either CBA/J (LPS sensitive) or C3H/HeJ (LPS resistant) mice. Both INDO and ASA fed to CBA/J mice significantly reduced endogenous PGE2 extractable from the uteri of hormonally pseudopregnant mice after deciduoma induction. Feeding INDO at doses up to 30 micrograms/ml from day 2.5 of pregnancy impaired but failed to completely block implantation in CBA/J mice, and with daily administration, some of the mice became sick: all of the implants in sick mice resorbed. INDO at doses of 150-200 micrograms per day known to inhibit implantation in vivo by sufficiently blocking PGE2 synthesis, was injected on one or more days beginning after the time of implantation. This failed to cause abortion in CBA/J mice and although some mice became ill, provided this happened after day 8.5 of pregnancy when sensitivity to the abortogenic effects of injected LPS decreased substantially in these mice, all implants in the sick mice were 'healthy' (i.e. non-resorbing). We were unable to increase the rate of resorption in syngeneically pregnant CD1 mice above 13% with 15 ml INDO in drinking water. Our data do not support the view that PGE2 represents an important intrauterine suppressor molecular blocking the processes mediating embryo death at the time of abortion. Spontaneous abortion in DBA/2-mated CBA/J mice appears to be determined by the level of bacterial LPS (endotoxin) and treatment with antibiotics or intralipid (which enhances endotoxin clearance), reduces the abortion rate. A sufficient dose of INDO may cause abortion, but the data taken together suggest this may be due to effects on the gut whereby permeability to bacterial LPS is increased.
*********************
3. Am J Reprod Immunol. 2007 Apr;57(4):262-9

Natural killer cell functional activity suppression by intravenous immunoglobulin, intralipid and soluble human leukocyte antigen-g.

Roussev RG, Ng SC, Coulam CB.
Millenova Immunology Laboratories, Chicago, IL, USA.

The purpose of this study was to compare the ability of intravenous immunoglobulin (IVIg), intralipid and soluble human leukocyte antigen (sHLA)-G to suppress natural killer (NK) cell cytotoxicity in an in vitro assay. Method of study Blood samples taken from 275 women experiencing reproductive failure were analyzed for NK cytotoxicity and the suppression of NK cytotoxicity by IVIg 4 and 2 mg/mL (n = 275), intralipid 18 and 9 mg/mL (n = 275) and sHLA-G 70 and 35 ng/mL (n = 50) using immunofluorescent labeled K562 cells as targets and flow cytometry. Results Natural killer cytotoxicity was suppressed in all samples. Among patients with normal NK cell activity, IVIg suppressed NK cytotoxicity by 44.9 +/- 8.1%, intralipid suppressed NK killing by 45.2 +/- 8.3% and sHLA-G suppressed by 49.0 +/- 9.2%. When specimens with abnormal NK activity were observed for suppression of cytotoxicity, IVIg suppressed by 38.9 +/- 5.4%, intralipid suppressed by 39.8 +/- 6.2% and sHLA-G suppressed by 39.9 +/- 5.0%. Conclusion Intravenous immunoglobulin, intralipid and sHLA-G suppressed NK cell cytotoxicity with equal efficacy in an in vitro assay.
***************
3. American Journal of Reproductive Immunology 59 (2008) 463–517 ª 2008 The Authors
472 Journal compilation ª 2008 Blackwell Munksgaard

Pregnancy Outcome after Intralipid
Infusion among Women Experiencing
Recurrent Pregnancy Loss
CB Coulam1,2, B Acacio3, JS Rinehart1, L Rinehart1,
S Ng2, RG Roussev2
1Rinehart Center for Reproductive Medicine, Evanston, IL, USA; 2Millenova
Immunology Laboratories, Chicago, IL, USA; 3Sher Institute for
Reproductive Medicine, Orange County, CA, USA

Objective: We have previously reported that Intralipid
suppresses natural killer (NK) cell cytotoxicity
both in vitro and in vivo. The current study was
undertaken to determine whether Intralipid treatment
is associated with increased live birth rates.
Methods: 79 patients with elevated NK cell activity
and a history of recurrent pre- or post-implantation
pregnancy loss were treated with IV intralipid,
2-4 ml of 20% solution. Of the 79 women, 68 had a
diagnosis of recurrent implantation failure and 11
experienced recurrent pregnancy loss. Recurrent
implantation failure was defined in this study as a
cumulative total of 8 cleaved embryos transferred or
4 blastocysts transferred with human chorionic
gonadotropin (hCG) serum concentrations less than
5 mIU/ml at 14 days after embryo transfer. Recurrent
pregnancy loss consisted of at least 2 or more
consecutive spontaneous abortions.
Results: Among the 68 women with a history of
recurrent implantation failure, 27 (40%) became
pregnant after in vitro fertilization and embryo
transfer with intralipid treatment. Four of the 68
patients were over the age of 40 years and none of
these became pregnant. Of 64 women under the age
of 40 years who were experiencing recurrent
implantation failure with elevated NK cell activity,
the pregnancy rate per cycle was 42%. Ten of the 11
(91%) women experiencing recurrent pregnancy
loss had a successful pregnancy.
Conclusion: Intralipid is effective in enhancing live
birth rates among women with elevated NK cell
cytotoxicity and a history of recurrent implantation
failure and recurrent pregnancy loss.

*****************
4.Am J Reprod Immunol. 2008 Sep;60(3):258-63.
Duration of Intralipid's Suppressive Effect on NK Cell's Functional Activity.
Roussev RG, Acacio B, Ng SC, Coulam CB.
Millenova Immunology Laboratories, Chicago, IL, USA.
Background In vitro investigations have revealed the ability of intralipids to suppress natural killer (NK) cytotoxicity. Evidence from both animal and human studies suggests that intralipid administered intravenously may enhance implantation and maintenance of pregnancy when the patient has an abnormal NK cell level or function. Problem The aim of this study was to establish the duration and efficacy of Intralipids suppressive effect on NK cell functional activity. Method of study Fifty patients with abnormal NK activity results (NKa) received intralipid 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 was performed by flow cytometry using K562 cells as targets. Results Fifty women with abnormal NKa-testing received intralipid infusions. 39 (78%) showed NKa suppression within the normal range the first week after infusion, 11 (22%), showed suppression, but still above the normal threshold. They received second infusion 2-3 weeks later. In 10, the Nka activity was normalized the following week. Four patients had three intralipid infusions in 2-week periods in between and after the third infusion, and all showed NKa normal activity. In 47 patients the suppressive effect of the Intralipid after the normalization of NKa lasted between 6 and 9 weeks, in two patients this benefit lasted 5 weeks, and in one patient the effect was 4 weeks. Conclusion Intralipid is effective in suppressing in vivo abnormal NK-cell functional activity. The results suggest that Intralipid can be used successfully as a therapeutic option to modulate abnormal NK activity in women with reproductive failure.
---------------------------------------------

If you know have questions about this document, please e-mail Jane Reed at edreed@pacwest.net.
Choice4
Joined: 21 Sep 2008
Posts: 180
PostPosted: Sun Jan 25, 2009 2:09 pm

INTRALIPID 20% – FINALLY AN EFFECTIVE, SAFE AND LOW COST ALTERNATIVE TO IVIG THERAPY.

It is no secret that SIRM has long advocated aggressive treatment of immunologic implantation dysfunction in women undergoing IVF. In cases where there has been Natural Killer Cell activation (Nka) (as evidenced by an abnormal K562 target cell test) we have championed the use of IVIG to down regulate (deactivate) the Nka. In this manner, many women who otherwise might not have achieved success with IVF have gone from infertility to family.

For us at SIRM , advocating the use of IVIG over the last decade, has come at a considerable price. Clearly, women requiring IVIG have been concerned about the cost (more than $4000 per dosage), reported side effects and, given the HIV/hepatitis scare, have been reluctant to receive a blood product. To make matters worse, under-informed critics have for unexplained reasons played on such unfounded fear often raising it to the level of alarm. The fact is that over the years we have administered IVIG to thousands of women, without a single report of viral transmission and few significant (but always transient) side effects.

About a year ago reports began to surface regarding a low cost (about ten times less than IVIG) synthetic product called Intralipid, which upon being infused more than a week prior to embryo transfer would lower Nka and further more, was virtually free of side effects.

About a year ago, we began evaluating the effect of Intralipid in patients who had activated Natural Killer cells, and for whom IVIG therapy would otherwise be indicated. Thus far we have treated more than 30 women with Nka using Intralipid 20%. More than 60% of the patients achieved viable ongoing pregnancies, showing Intralipid therapy to be at least as effective (and perhaps even more so) than IVIG. There were no significant side effects and patient tolerance of this treatment was high. We anticipate that patients receiving Intralipid will soon start reporting on their experience using Intralipid, on various discussion boards.

Against this background, SIRM physicians have collectively decided to virtually abandon further use of IVIG, in favor of Intralipid.

If you have any questions about Intralipid therapy , please don’t hesitate to contact an SIRM physician for more information.



Below are some clinical details about Intralipid:

INTRALIPID INFUSION: A SAFE AND INEXPENSIVE ALTERNATIVE TO IVIG FOR IMPLANTATION DYSFUNCTION:
Geoffrey Sher MD

Intralipid (IL), is a synthetic product composed of 10% soybean oil, 1,2% egg yolk phospholipids, 2.25% glycerin and water. Based on research performed at SIRM and elsewhere, infusion of IL lowers Natural Killer cell activation (Nka) as effectively as does, intravenous gammaglobulin (IVIG.) When indicated IL (as with IVIG) is infused 7-10 days prior to ET and one more time again after a positive pregnancy in women whose Nka is due to an autoimmune causes (antiphospholipid antibodies and/or antithyroid antibodies). In cases of alloimmune implantation dysfunction (DQa and/ HLA matching between the embryo recipient and the male partner) the same applies but in this situation the infusion is repeated at 2-4 week intervals until the 24th week of pregnancy.
We have supplanted IVIG with IL therapy in a significant number of women undergoing IVF , and who had immunologic embryo implantation dysfunction. The results thus far have been excellent, way beyond our initial expectations.
At last we now have a safe and inexpensive alternative to IVIG therapy…Intralipid! What is more, IL costs about 10 times less than IVIG, is not a blood product and is without significant side effects.
//////////////////////////////////
For the present, IVIG must still be regarded as the mainstay of treatment
Pia
Joined: 01 Aug 2008
Posts: 124
PostPosted: Sun Jan 25, 2009 6:01 pm

Wow thats impressive - thanks for all that info, its great.
Post new topic Reply to topic  
INTRALIPIDS All you need to know!!!!!!!! 
CAREFertility Forum Index » General Forum
Page 1 of 1
All times are GMT
  
  


CARE Fertility © 2009