Intralipid for Recurrent Miscarriage

Abortion, Spontaneous Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01788540
• Other study ID #: 12013
• Status: Completed
• Phase: Phase 4
• First received: February 7, 2013
• Last updated: January 24, 2018
• Start date: February 2013
• Est. completion date: September 2016

Study information

• Verified date: January 2018
• Source: Woman's Health University Hospital, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous

Intervention

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

Locations

Country	Name	City	State
Egypt	Kasr el ainy hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ongoing pregnancy rate	clinical pregnancy continue after 12 weeks gestational age	10 months
Other	abortion rate		12 months
Primary	chemical pregnancy rate	Positive pregnancy test in blood as measured by quantitative B- hCG level	10 months
Secondary	clinical pregnancy rate,	Confirmed pregnancy at 7 weeks by ultrasound visualization of gestational sac and positive fetal pulsations	10 months