Intralipid for Repeated Implantation Failure

Study Overview
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Brief Summary
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Intralipid infusion can improve outcome in women with recurrent Intracytoplasmic sperm injection ( ICSI) failure due to elevated TH1 cytokine response.

Detailed Description
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Infertile patients undergoing Intracytoplasmic Sperm Injection (ICSI) cycle with history of repeated implantation failure, intralipid will be given to the intervention group. The primary outcome measure is the clinical pregnancy rate, secondary outcome measures implantation rate, ongoing pregnancy rate, abortion rate.

Official Title
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Does Intralipid Infusion Improve the Implantation Rate in Repeated Implantation Failure: a Randomized Controlled Trial

Conditions
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Infertility

Intervention / Treatment
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* Drug: intralipid
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infertile patients undergoing ICSI cycle with history of repeated implantation failure Exclusion Criteria: Disturbances of normal fat metabolism such as pathologic hyperlipemia Allergic to it; or to eggs, soybean oil, or safflower oil. Severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder. Uterine fibroid, endometrial polyp, endometriosis and hydrosalpinx.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>Saline 0.9% IV infusion between day 4 and 9 of ovarian stimulation & another dose when got pregnant within the 1st week of positive pregnancy test | Drug: Saline<br>* Saline 0.9% IV infusion between day4 and 9 of ovarian stimulation & another dose when got pregnant within the 1st week of positive pregnancy test<br>* Other names: Saline 0.9%;|
| Experimental: intralipid<br>IV infusion of intralipid 20% between day4 and 9 of ovarian stimulation & another dose when got pregnant within the 1st week of positive pregnancy test | Drug: intralipid<br>* IV infusion of intralipid 20% between day4 and 9 of ovarian stimulation & another dose when got pregnant within the 1st week of positive pregnancy test<br>* Other names: intralipid 20%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate | pregancy sac with fetal heart activity | 10 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate | the number of gestational sacs divided by the number of embryos transferred | 10 month | 
| ongoing pregnancy rate | clinical pregnancy continue after 12 weeks gestational age | 14 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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repeated implantation failure, intralipid