Skip to main content
OpenTrials
Completed

NCT Number: NCT01788540

Intralipid for Recurrent Miscarriage

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Abortion, Spontaneous Abortion, Habitual Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Kasr el ainy hospital

Cairo, 12211, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intralipid

Drug

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%

Primary outcomes

  1. chemical pregnancy rate

    Time frame: 10 months

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

Secondary outcomes

  1. clinical pregnancy rate,

    Time frame: 10 months

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

Other outcomes

  1. ongoing pregnancy rate

    Time frame: 10 months

    clinical pregnancy continue after 12 weeks gestational age

  2. abortion rate

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Woman's Health University Hospital, Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 11, 2013
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.