NCT01788540

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

3.5 years

First QC Date

February 7, 2013

Last Update Submit

January 24, 2018

Conditions

Abortion, SpontaneousAbortion, Habitual

Keywords

Recurrent miscarriageImplantation failureIntralipidICSI / IVF failure

Outcome Measures

Primary Outcomes (1)

  • chemical pregnancy rate

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

    10 months

Secondary Outcomes (1)

  • clinical pregnancy rate,

    10 months

Other Outcomes (2)

  • ongoing pregnancy rate

    10 months

  • abortion rate

    12 months

Study Arms (2)

Intralipid

EXPERIMENTAL

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

Control

NO INTERVENTION

No intervention

Interventions

IntralipidDRUG

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

Also known as: intralipid 20%
Intralipid

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr el ainy hospital

Cairo, 12211, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 27614789DERIVED

MeSH Terms

Conditions

Abortion, SpontaneousAbortion, Habitual

Interventions

soybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Dina M Dakhly, M.D.

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 11, 2013

Study Start

February 1, 2013

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

January 26, 2018

Record last verified: 2018-01

Locations

EG(1)