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Intralipid Therapy for Women 35-40 Years With Positive Natural Killer Cells Undergoing Intracytoplasmic Sperm Injection (ICSI)

Primary Purpose

Infertility

Status
Terminated
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Intralipid infusion
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Infertility, intralipid, invitro fertilization, repeated implantation failure, repeated miscarriage

Eligibility Criteria

35 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing Intracytoplasmic sperm injection (ICSI ) cycle.

Exclusion Criteria:

  • women above 40years or less than 35 years
  • Disturbances of normal fat metabolism such as pathologic hyperlipidemia,Lipoid nephrosis or acute pancreatitis with hyperlipidemia.
  • Allergic to eggs, soybean oil, or safflower oil.
  • Severe liver disease, kidney disease, lung disease, anemia, blood coagulation disorder.
  • Uterine fibroid, endometrial polyp, endometriosis and hydrosalpinx.
  • Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies (Immunoglobulin G or M)[IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice).
  • Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
  • Fibroids distorting uterine cavity.
  • Abnormal parental karyotype.

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intralipid infusion

Control group

Arm Description

100 Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing ICSI cycle.

100 Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing ICSI cycle.

Outcomes

Primary Outcome Measures

Clinical pregnancy rate
Intrauterine gestational sac with fatal pole and positive pulsation

Secondary Outcome Measures

Chemical pregnancy
positive pregnancy test (serum BHCG) measured 16 days following embryo transfer
implantation rate
the number of gestational sacs divided by the number of embryos transferred
ongoing pregnancy rate
clinical pregnancy continue after 12 weeks gestational age
Miscarriage rate
Ectopic rate

Full Information

First Posted
August 3, 2013
Last Updated
March 30, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT01916798
Brief Title
Intralipid Therapy for Women 35-40 Years With Positive Natural Killer Cells Undergoing Intracytoplasmic Sperm Injection (ICSI)
Official Title
Intravenous Intralipid Therapy Among Women Aged 35-40 Years With Positive Peripheral Blood Natural Killer Cells Undergoing in Vitro Fertilization-Embryo Transfer: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Not able to recruit the number required and due to financial difficulty to pay for intralipids
Study Start Date
May 2013 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Intralipid can suppress natural killer cells that are known to be involve in repeated implantation failure and recurrent miscarriages.Intralipid is made of purified soybean oil, egg phospholipids, glycerol and water. It provides essential fatty acids, linoleic acid, omega- 3 and 6 fatty acids and alpha-linolenic acid. The effects of Intralipid in suppressing natural killer cell activity (NKa) were found to be comparable to intravenous immunoglobulin (IVIG) by laboratory experiments.We will study the effect of intralipid infusion on the pregnancy outcome of women aged 35-40 years with history of repeated implantation failure of miscarriage and who have positive peripheral blood natural killer cells

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, intralipid, invitro fertilization, repeated implantation failure, repeated miscarriage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intralipid infusion
Arm Type
Active Comparator
Arm Description
100 Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing ICSI cycle.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
100 Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing ICSI cycle.
Intervention Type
Drug
Intervention Name(s)
Intralipid infusion
Intervention Description
IV infusion of 250 ml of intralipid 20% solution at the day of Ovum pick up & another dose at the day of embryo Transfer.
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Intrauterine gestational sac with fatal pole and positive pulsation
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Chemical pregnancy
Description
positive pregnancy test (serum BHCG) measured 16 days following embryo transfer
Time Frame
10 months
Title
implantation rate
Description
the number of gestational sacs divided by the number of embryos transferred
Time Frame
10 months
Title
ongoing pregnancy rate
Description
clinical pregnancy continue after 12 weeks gestational age
Time Frame
10 months
Title
Miscarriage rate
Time Frame
12 months
Title
Ectopic rate
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing Intracytoplasmic sperm injection (ICSI ) cycle. Exclusion Criteria: women above 40years or less than 35 years Disturbances of normal fat metabolism such as pathologic hyperlipidemia,Lipoid nephrosis or acute pancreatitis with hyperlipidemia. Allergic to eggs, soybean oil, or safflower oil. Severe liver disease, kidney disease, lung disease, anemia, blood coagulation disorder. Uterine fibroid, endometrial polyp, endometriosis and hydrosalpinx. Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies (Immunoglobulin G or M)[IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice). Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy). Fibroids distorting uterine cavity. Abnormal parental karyotype.
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
22340745
Citation
Coulam CB, Acacio B. Does immunotherapy for treatment of reproductive failure enhance live births? Am J Reprod Immunol. 2012 Apr;67(4):296-304. doi: 10.1111/j.1600-0897.2012.01111.x. Epub 2012 Feb 16.
Results Reference
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PubMed Identifier
22196107
Citation
Shreeve N, Sadek K. Intralipid therapy for recurrent implantation failure: new hope or false dawn? J Reprod Immunol. 2012 Jan;93(1):38-40. doi: 10.1016/j.jri.2011.11.003. Epub 2011 Dec 21.
Results Reference
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Intralipid Therapy for Women 35-40 Years With Positive Natural Killer Cells Undergoing Intracytoplasmic Sperm Injection (ICSI)

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