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Intralipid for Recurrent Miscarriage

Primary Purpose

Abortion, Spontaneous, Abortion, Habitual

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Intralipid
Sponsored by
Woman's Health University Hospital, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abortion, Spontaneous focused on measuring Recurrent miscarriage, Implantation failure, Intralipid, ICSI / IVF failure

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Kasr el ainy hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intralipid

Control

Arm Description

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

No intervention

Outcomes

Primary Outcome Measures

chemical pregnancy rate
Positive pregnancy test in blood as measured by quantitative B- hCG level

Secondary Outcome Measures

clinical pregnancy rate,
Confirmed pregnancy at 7 weeks by ultrasound visualization of gestational sac and positive fetal pulsations

Full Information

First Posted
February 7, 2013
Last Updated
January 24, 2018
Sponsor
Woman's Health University Hospital, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT01788540
Brief Title
Intralipid for Recurrent Miscarriage
Official Title
The Role of Intralipid in Natural Killer Cell Positive Cases With Recurrent Miscarriages Undergoing IVF/ICSI Cycles: a Double Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Woman's Health University Hospital, Egypt

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion, Spontaneous, Abortion, Habitual
Keywords
Recurrent miscarriage, Implantation failure, Intralipid, ICSI / IVF failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intralipid
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Intralipid
Other Intervention Name(s)
intralipid 20%
Intervention Description
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
Primary Outcome Measure Information:
Title
chemical pregnancy rate
Description
Positive pregnancy test in blood as measured by quantitative B- hCG level
Time Frame
10 months
Secondary Outcome Measure Information:
Title
clinical pregnancy rate,
Description
Confirmed pregnancy at 7 weeks by ultrasound visualization of gestational sac and positive fetal pulsations
Time Frame
10 months
Other Pre-specified Outcome Measures:
Title
ongoing pregnancy rate
Description
clinical pregnancy continue after 12 weeks gestational age
Time Frame
10 months
Title
abortion rate
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina M Dakhly, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr el ainy hospital
City
Cairo
ZIP/Postal Code
12211
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
27614789
Citation
Dakhly DM, Bayoumi YA, Sharkawy M, Gad Allah SH, Hassan MA, Gouda HM, Hashem AT, Hatem DL, Ahmed MF, El-Khayat W. Intralipid supplementation in women with recurrent spontaneous abortion and elevated levels of natural killer cells. Int J Gynaecol Obstet. 2016 Dec;135(3):324-327. doi: 10.1016/j.ijgo.2016.06.026. Epub 2016 Aug 30.
Results Reference
derived

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Intralipid for Recurrent Miscarriage

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