Back to resultsIntralipid for Repeated Implantation Failure (Intralipid)
Primary Purpose
Infertility
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
intralipid
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring repeated implantation failure, intralipid
Eligibility Criteria
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.
Sites / Locations
- Kasr Al-ainy hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
control
intralipid
Arm Description
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
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
Outcomes
Primary Outcome Measures
clinical pregnancy rate
pregancy sac with fetal heart activity
Secondary Outcome Measures
implantation rate
the number of gestational sacs divided by the number of embryos transferred
ongoing pregnancy rate
clinical pregnancy continue after 12 weeks gestational age
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01540591
Brief Title
Intralipid for Repeated Implantation Failure
Acronym
Intralipid
Official Title
Does Intralipid Infusion Improve the Implantation Rate in Repeated Implantation Failure: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Intralipid infusion can improve outcome in women with recurrent Intracytoplasmic sperm injection ( ICSI) failure due to elevated TH1 cytokine response.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
repeated implantation failure, intralipid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
intralipid
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
intralipid
Other Intervention Name(s)
intralipid 20%
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Saline 0.9%
Intervention Description
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
Primary Outcome Measure Information:
Title
clinical pregnancy rate
Description
pregancy sac with fetal heart activity
Time Frame
10 month
Secondary Outcome Measure Information:
Title
implantation rate
Description
the number of gestational sacs divided by the number of embryos transferred
Time Frame
10 month
Title
ongoing pregnancy rate
Description
clinical pregnancy continue after 12 weeks gestational age
Time Frame
14 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed El-khayat, M.D.
Organizational Affiliation
Faculty of medicine, Cairo University, Cairo, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Al-ainy hospital
City
Cairo
ZIP/Postal Code
12211
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Intralipid for Repeated Implantation Failure
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