Intralipid for Repeated Implantation Failure

NCT ID: NCT01540591

Last Updated: 2016-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-06-30

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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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control

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

intralipid

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

Group Type EXPERIMENTAL

intralipid

Intervention Type DRUG

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

Interventions

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intralipid

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

Saline

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

Intervention Type DRUG

Other Intervention Names

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intralipid 20% Saline 0.9%

Eligibility Criteria

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Inclusion Criteria

* Infertile patients undergoing ICSI cycle with history of repeated implantation failure

Exclusion Criteria

1. Disturbances of normal fat metabolism such as pathologic hyperlipemia
2. Allergic to it; or to eggs, soybean oil, or safflower oil.
3. Severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder.
4. Uterine fibroid, endometrial polyp, endometriosis and hydrosalpinx.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Waleed El-khayat

Assisstant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Waleed El-khayat, M.D.

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicine, Cairo University, Cairo, Egypt

Locations

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Kasr Al-ainy hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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22012

Identifier Type: -

Identifier Source: org_study_id

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