Intralipid for Repeated Implantation Failure
Intralipid
Does Intralipid Infusion Improve the Implantation Rate in Repeated Implantation Failure: a Randomized Controlled Trial
1 other identifier
interventional
200
1 country
1
Brief Summary
Intralipid infusion can improve outcome in women with recurrent Intracytoplasmic sperm injection ( ICSI) failure due to elevated TH1 cytokine response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 23, 2012
CompletedFirst Posted
Study publicly available on registry
February 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedSeptember 16, 2016
September 1, 2016
1.6 years
February 23, 2012
September 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
clinical pregnancy rate
pregancy sac with fetal heart activity
10 month
Secondary Outcomes (2)
implantation rate
10 month
ongoing pregnancy rate
14 month
Study Arms (2)
control
PLACEBO COMPARATORSaline 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
intralipid
EXPERIMENTALIV infusion of intralipid 20% between day4 and 9 of ovarian stimulation \& another dose when got pregnant within the 1st week of positive pregnancy test
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Infertile patients undergoing ICSI cycle with history of repeated implantation failure
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Kasr Al-ainy hospital
Cairo, 12211, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Waleed El-khayat, M.D.
Faculty of medicine, Cairo University, Cairo, Egypt
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisstant professor
Study Record Dates
First Submitted
February 23, 2012
First Posted
February 29, 2012
Study Start
February 1, 2012
Primary Completion
September 1, 2013
Study Completion
June 1, 2014
Last Updated
September 16, 2016
Record last verified: 2016-09