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Effect Of Intravenous IntralipidTherapyon Pregnancy Outcome in Women With History of Recurrent Implantation Failure Undergoing Intracytoplasmic Sperm Injection-Embryo Transfer Cycle: A Randomized Controlled Trial

Primary Purpose

Infertility Due to Nonimplantation

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
intralipid 20%
Sponsored by
King Fahad Medical City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility Due to Nonimplantation focused on measuring infertility , implantion failure, intracytoplasmic sperm injection

Eligibility Criteria

21 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • age < 42 years
  • BMI < 30 kg/m2
  • history of 3 or more recurrent implantation failure undergoing Intracytoplasmic Sperm Injection (ICSI ) cycle.

exclusion criteria

  • women with medical contraindications of intralipidinfusion.
  • uterine fibroid.
  • endometrial polyp.
  • endometriosis,hydrosalpinx.
  • intrauterine adhesion and uterine anomalies.
  • Women with positive thrombophilia screen.
  • diminished ovarian reserve.
  • severe male factor infertility .
  • chronic medical illnesses which may contribute in impaired chance of pregnancy .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    treatment group who recived intralipid

    control group

    Arm Description

    71 patients who recived intralipid on day of embryo transfer day, pregnancy day.

    71 patient not recived intralipid

    Outcomes

    Primary Outcome Measures

    pregnancy rate
    number of patient with positive b-hcg level 14 day post embryo transfer day.over the study population number in study period.

    Secondary Outcome Measures

    miscarrage rate
    number of patient with miscarrage over study population number in study period
    live birth rate
    number of patient with delivery after 28 week gestation over study population number in study period.

    Full Information

    First Posted
    December 5, 2017
    Last Updated
    December 11, 2017
    Sponsor
    King Fahad Medical City
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03374163
    Brief Title
    Effect Of Intravenous IntralipidTherapyon Pregnancy Outcome in Women With History of Recurrent Implantation Failure Undergoing Intracytoplasmic Sperm Injection-Embryo Transfer Cycle: A Randomized Controlled Trial
    Official Title
    Effect Of Intravenous IntralipidTherapyon Pregnancy Outcome in Women With History of Recurrent Implantation Failure Undergoing Intracytoplasmic Sperm Injection-Embryo Transfer Cycle: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    June 30, 2017 (Actual)
    Study Completion Date
    June 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    King Fahad Medical City

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient withunexplained recurrentimplantation failure (RIF) undergoIntracytoplasmic sperm injection (ICSI).
    Detailed Description
    the aim to evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient withunexplained recurrentimplantation failure (RIF) undergoIntracytoplasmic sperm injection (ICSI). A total of 142 patients with history of unexplained RIF3 or more cycles were included in the study. Patient were randomized into two groups, study group (n=71) and control group (n=71). The study groupreceivedintralipid 20%infusionon the day of embryo transfer (ET) and a second dose on the day of pregnancy test. The control group underwent ET without intralipidinfusion.Allpatientswereclosely monitored for any side effectsincluding allergic reactions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility Due to Nonimplantation
    Keywords
    infertility , implantion failure, intracytoplasmic sperm injection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    To evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient withunexplained recurrentimplantation failure (RIF) undergoIntracytoplasmic sperm injection (ICSI). A total of 142 patients with history of unexplained RIF3 or more cycles were included in the study. Patient were randomized into two groups, study group (n=71) and control group (n=71). The study groupreceivedintralipid 20%infusionon the day of embryo transfer (ET) and a second dose on the day of pregnancy test. The control group underwent ET without intralipidinfusion.Allpatientswereclosely monitored for any side effectsincluding allergic reactions.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    142 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment group who recived intralipid
    Arm Type
    Experimental
    Arm Description
    71 patients who recived intralipid on day of embryo transfer day, pregnancy day.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    71 patient not recived intralipid
    Intervention Type
    Drug
    Intervention Name(s)
    intralipid 20%
    Intervention Description
    milky soulation for energey supplement.
    Primary Outcome Measure Information:
    Title
    pregnancy rate
    Description
    number of patient with positive b-hcg level 14 day post embryo transfer day.over the study population number in study period.
    Time Frame
    14 day post embryo transfer day
    Secondary Outcome Measure Information:
    Title
    miscarrage rate
    Description
    number of patient with miscarrage over study population number in study period
    Time Frame
    miscarrage before 20 week gestation
    Title
    live birth rate
    Description
    number of patient with delivery after 28 week gestation over study population number in study period.
    Time Frame
    delivery after 28 week gestation

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    biologicaly female
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    42 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age < 42 years BMI < 30 kg/m2 history of 3 or more recurrent implantation failure undergoing Intracytoplasmic Sperm Injection (ICSI ) cycle. exclusion criteria women with medical contraindications of intralipidinfusion. uterine fibroid. endometrial polyp. endometriosis,hydrosalpinx. intrauterine adhesion and uterine anomalies. Women with positive thrombophilia screen. diminished ovarian reserve. severe male factor infertility . chronic medical illnesses which may contribute in impaired chance of pregnancy .
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    solaiman s alobaid, MD
    Organizational Affiliation
    King Fahad Medical City
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Effect Of Intravenous IntralipidTherapyon Pregnancy Outcome in Women With History of Recurrent Implantation Failure Undergoing Intracytoplasmic Sperm Injection-Embryo Transfer Cycle: A Randomized Controlled Trial

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