Intralipid for Recurrent Miscarriage

January 24, 2018 updated by: Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt

The Role of Intralipid in Natural Killer Cell Positive Cases With Recurrent Miscarriages Undergoing IVF/ICSI Cycles: a Double Blind Randomized Controlled Trial

Intralipid infusion can improve the outcome in NK cells positive females with history of recurrent miscarriages undergoing IVF/ICSI cycles.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12211
        • Kasr el ainy hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Couples with unexplained secondary infertility
  • Three or more prior consecutive clinical miscarriages after either spontaneous pregnancy or after IVF/ICSI.
  • Elevated natural killer (NK) cells CD16, CD56 and cells with both CD16/CD56 >12%.

Exclusion Criteria:

  • Age above forty years old.
  • Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice).
  • Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
  • Abnormal parental karyotype.
  • Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention
Experimental: Intralipid

IV infusion of intralipid 20% is administrated on the day of vaginal egg collection in a dose of 9 mg/ml total blood volume corresponding to intralipid 2 ml 20% diluted in 250 ml saline over 30-60 minutes.

the intralipid infusion is then repeated within the one week of positive pregnancy test and every 2 weeks till end of first trimester
Drug: Intralipid
IV infusion of intralipid 20% is administrated on the day of vaginal egg collection in a dose of 9 mg/ml total blood volume corresponding to intralipid 2 ml 20% diluted in 250 ml saline over 30-60 minutes.the intralipid infusion is then repeated within the 1st week of positive pregnancy test and every 2 weeks till end of first trimester
Other Names:
  • intralipid 20%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
chemical pregnancy rate
Time Frame: 10 months
Positive pregnancy test in blood as measured by quantitative B- hCG level
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate,
Time Frame: 10 months
Confirmed pregnancy at 7 weeks by ultrasound visualization of gestational sac and positive fetal pulsations
10 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
ongoing pregnancy rate
Time Frame: 10 months
clinical pregnancy continue after 12 weeks gestational age
10 months
abortion rate
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Woman's Health University Hospital, Egypt

Investigators

  • Principal Investigator: Dina M Dakhly, M.D., Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

February 7, 2013

First Submitted That Met QC Criteria

February 8, 2013

First Posted (Estimate)

February 11, 2013

Study Record Updates

Last Update Posted (Actual)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 24, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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