Trial record 2 of 48 for:    Open Studies | "Abortion, Spontaneous"

Intralipid for Recurrent Unexplained Miscarriage

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Woman's Health University Hospital, Egypt
Sponsor:
Information provided by (Responsible Party):
Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier:
NCT01788540
First received: February 7, 2013
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

Intralipid infusion can improve the outcome in women with history of recurrent Unexplained miscarriages undergoing IVF/ICSI cycles.


Condition Intervention Phase
Abortion, Spontaneous
Abortion, Habitual
Drug: Intralipid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Role of Intralipid in Cases of Recurrent Unexplained Miscarriage Undergoing IVF / ICSI Cycles, a Prospective Randomized Control Study

Resource links provided by NLM:


Further study details as provided by Woman's Health University Hospital, Egypt:

Primary Outcome Measures:
  • chemical pregnancy rate [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Positive pregnancy test in blood as measured by quantitative B- hCG level


Secondary Outcome Measures:
  • clinical pregnancy rate, [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Confirmed pregnancy at 7 weeks by ultrasound visualization of gestational sac and positive fetal pulsations


Other Outcome Measures:
  • ongoing pregnancy rate [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    clinical pregnancy continue after 12 weeks gestational age

  • abortion rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: February 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: intralipid 20%
No Intervention: Control
No intervention

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • history of Recurrent unexplained miscarriage (3 or more times)

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01788540

Contacts
Contact: Dina M Dakhly, M.D. 01003498919 ext +2 Dinadakhly@gmail.com

Locations
Egypt
Kasr el ainy hospital Recruiting
Cairo, Egypt, 12211
Contact: Dina M Dakhly, M.D.    01003498919 ext +2    Dinadakhly@mail.com   
Principal Investigator: Dina M Dakhly, M.D.         
Sponsors and Collaborators
Woman's Health University Hospital, Egypt
Investigators
Principal Investigator: Dina M Dakhly, M.D. Faculty of medicine , cairo university
  More Information

No publications provided

Responsible Party: Dina Mohamed Refaat Dakhly, M.D., Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT01788540     History of Changes
Other Study ID Numbers: 12013
Study First Received: February 7, 2013
Last Updated: July 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Woman's Health University Hospital, Egypt:
Recurrent miscarriage
Implantation failure
Intralipid
ICSI / IVF failure

Additional relevant MeSH terms:
Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications

ClinicalTrials.gov processed this record on September 22, 2014