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Trial record 58 of 179 for:    Phospholipids

Effect of Intralipid Infusion in Patients With Recurrent Implantation Failure

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ClinicalTrials.gov Identifier: NCT02865785
Recruitment Status : Unknown
Verified August 2016 by Mostafa Fouad Gomaa, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : August 12, 2016
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
Mostafa Fouad Gomaa, Ain Shams University

Brief Summary:
The aim of present study is to evaluate the effect of intralipid 20% infusion, once between days 4 and 9 of the ovarian stimulation, and again within 7 days of a positive pregnancy test on clinical pregnancy rates in women with unexplained recurrent implantation failure.

Condition or disease Intervention/treatment Phase
Subfertility Drug: Intralipid 20% Drug: Placebo Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Intralipid Infusion in Patients With Recurrent Implantation Failure (A Randomized Controlled Trial)
Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : August 2017

Arm Intervention/treatment
Active Comparator: Study Group
This group will include 160 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of intralipid 20% (100 mL of intralipid 20% diluted in 250 mL sterile i.v. saline administered i.v. over two hours), once between days 4 and 9 of the ovarian stimulation, and again within 7 days of a positive pregnancy test.
Drug: Intralipid 20%
intralipid D4-9 of induction ovulation to be repeated within 7 days of positive pregnancy test.
Other Name: lipofundin 20%

Placebo Comparator: Placebo Group
This group will include 160 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of placebo, once between days 4 and 9 of the ovarian stimulation, and again within 7 days of a positive pregnancy test.
Drug: Placebo
saline infusion D4-9 of induction of ovulation to be repeated within 7 days of positive pregnancy test.
Other Name: saline 0.9%




Primary Outcome Measures :
  1. Live birth rate [ Time Frame: 38 gestational weeks ]

Secondary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 6 gestational weeks ]
  2. Chemical pregnancy rate [ Time Frame: 6 gestational weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 20-38 years of age.
  2. Recurrent implantation failure, defined as failure to achieve a recognizable intrauterine gestational sac by ultrasonography after transfer of at least four good-quality embryos in a minimum of three fresh or frozen IVF cycles (Coughlan et al, 2014).

    Good-quality embryos will be defined as those characterized by absence of multinucleated blastomeres, four or five blastomeres on day 2, seven or more cells on day 3, and ≤ 20% anucleated fragments (Van Royen et al, 1999).

  3. Normal transvaginal ultrasonography
  4. Normal office hysteroscopy.
  5. Normal hysterosalpingography.
  6. Absence of any structural pathological findings in laparoscopy.
  7. Normal male and female karyotyping.
  8. Normal endocrinological profile during ovarian stimulation
  9. Normal anti-cardiolipin antibody IgG, IgM and lupus anticoagulant.
  10. Normal thrombophilia screen in the form of protein C, protein S, anti thrombin III, factor V mutations and factor V leiden.
  11. Elevated uterine natural killer cells (uNK) density in luteal phase endometrial biopsy, defined as ≥ 5% CD16+ CD56+ cells in the stroma underlying the luminal epithelium (Tang et al, 2013; Quenby et al, 2005).
  12. Normal parameters of male semen analysis according to WHO criteria 2010.
  13. Written and signed informed consent by the patient to participate in the study.

Exclusion Criteria:

  1. Age more than 38 years.
  2. Less than 3 failed IVF cycles.
  3. Poor embryo quality in previous IVF trials.
  4. Abnormal ultrasonographic finding, e.g. endometrial polyps, fibroids or ovarian cysts.
  5. Abnormal hysteroscopic finding, e.g. endometrial polyps, endometrial hyperplasia or fibroid.
  6. Abnormal hysterosalpingographic finding, e.g. hydrosalpinx or peritoneal adhesions.
  7. Abnormal male or female karyotyping.
  8. Abnormal endocrinological profile during ovarian stimulation, e.g. hyperprolactinemia
  9. Expected poor ovarian responders according to Bologna criteria (Ferraretti et al, 2011), i.e. presence of at least two of the following three features:

    • Presence of risk factor for poor ovarian response (POR) represented by advanced maternal age (≥ 40 years) or any other genetic or acquired conditions possibly linked to a reduced amount of resting follicles.
    • A previous POR, represented by a cycle cancelled (following the development of less than three growing follicles) or the collection of less than four oocytes in response to an ovarian stimulation protocol of at least 150 IU FSH per day.
    • An abnormal ovarian reserve test (i.e. AFC < 5-7 follicles or AMH < 0.5-1.1 ng/ml).
  10. Positive anticardiolipin antibodies or lupus anticoagulant.
  11. Positive thrombophilia screen.
  12. Normal uterine natural killer cells (uNK) density in luteal phase endometrial biopsy, defined as < 5% CD16+ CD56+ cells in the stroma underlying the luminal epithelium (Tang et al, 2013; Quenby et al, 2005).
  13. Abnormal semen analysis parameters according to WHO criteria 2010.
  14. Any chronic medical disorder, e.g. hypertension, autoimmune disorders, … etc.
  15. Known allergy to any of the intralipid constituents.
  16. Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865785


Contacts
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Contact: Khaled Afifi, MBBCH 01009981222 DrKhaledAfifi@hotmail.com

Locations
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Egypt
AinShams Maternity Hospital Recruiting
Cairo, Egypt, 002
Contact: Khaled Afifi, MBBCH    01009981222    DrKhaledAfifi@hotmail.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Khaled Afifi, MBBCH Resident of O&G

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Responsible Party: Mostafa Fouad Gomaa, Dr, Ain Shams University
ClinicalTrials.gov Identifier: NCT02865785     History of Changes
Other Study ID Numbers: Intralipid-RIF
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mostafa Fouad Gomaa, Ain Shams University:
recurrent implantation failure
intralipid
uterine natural killer cells

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions