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The Effect of LMWH on ICSI in Patients With Unexplained Infertility and Negative Immunological Markers

Primary Purpose

Unexplained Infertility

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
LMWH
0.9% saline solution
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unexplained Infertility

Eligibility Criteria

undefined - 38 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • age less than 38 years
  • at least 12 months of infertility
  • women with unexplained infertility

Exclusion Criteria:

  • age more than or equals 38 years
  • serum AMH level less than or equals 1 ng/ml
  • patients of anticoagulant therapy
  • immune-compromised patients
  • patients with contraindications to low molecular weight heparin
  • positive immunological markers
  • patients with other than unexplained infertility
  • male factor infertility
  • refusal of participation
  • patients with unexpected poor or over response during induction of ovulation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    LMWH supplementation

    0.9% saline solution

    Arm Description

    40 mg of enoxaparin injected subcutaneously every 24 hours starting the day of ovum pick-up to the documentation of fetal life by ultrasound at 7 weeks of gestation

    0.9% saline injected subcutaneously every 24 hours starting the day of ovum pick-up to the documentation of fetal life by ultrasound at 7 weeks of gestation

    Outcomes

    Primary Outcome Measures

    Live birth Rate

    Secondary Outcome Measures

    Clinical Pregnancy Rate
    Biochemical Pregnancy Rate

    Full Information

    First Posted
    August 5, 2016
    Last Updated
    August 11, 2016
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02861105
    Brief Title
    The Effect of LMWH on ICSI in Patients With Unexplained Infertility and Negative Immunological Markers
    Official Title
    The Effect of LMWH on ICSI Outcome in Patients With Unexplained Infertility and Negative Immunological Markers; a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the efficacy of LMWH treatment in women with unexplained infertility and negative immunological markers undergoing ICSI.
    Detailed Description
    Inclusion criteria: patients undergoing 1st trial ICSI unexplained infertility negative immunological markers including ACL abs, LAC, ANA, ATA, AnitdsDNA Exclusion criteria: previous IVF/ICSI Any cause of infertility Suspected and/or unexpected poor response during ovulation induction positive immunological markers Age > 40 years. All participants will undergo IVF/ICSI cycle using the Long luteal phase protocol. the dose of gonadotropins will be calculated according to patient age and BMI. All patients will have 2-3 embryos transferred at D5 according to their age. the primary outcome will be LBR. secondary outcomes will include biochemical pregnancy rate and clinical pregnancy rate.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Unexplained Infertility

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    716 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LMWH supplementation
    Arm Type
    Active Comparator
    Arm Description
    40 mg of enoxaparin injected subcutaneously every 24 hours starting the day of ovum pick-up to the documentation of fetal life by ultrasound at 7 weeks of gestation
    Arm Title
    0.9% saline solution
    Arm Type
    Placebo Comparator
    Arm Description
    0.9% saline injected subcutaneously every 24 hours starting the day of ovum pick-up to the documentation of fetal life by ultrasound at 7 weeks of gestation
    Intervention Type
    Drug
    Intervention Name(s)
    LMWH
    Other Intervention Name(s)
    Clexane, Enoxaparin
    Intervention Description
    LMWH will be given on daily basis subcutaneously every 24 hours starting one day after ovum pick up till documentation of fetal life by ultrasound at 7 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    0.9% saline solution
    Other Intervention Name(s)
    0.9% sodium chloride solution
    Intervention Description
    0.9% saline solution will be given subcutaneously every 24 hours starting one day after ovum pick up till documentation of fetal life by ultrasound at 7 weeks.
    Primary Outcome Measure Information:
    Title
    Live birth Rate
    Time Frame
    at delivery
    Secondary Outcome Measure Information:
    Title
    Clinical Pregnancy Rate
    Time Frame
    at 7 weeks of gestation
    Title
    Biochemical Pregnancy Rate
    Time Frame
    14 days after embryo transfer

    10. Eligibility

    Sex
    Female
    Maximum Age & Unit of Time
    38 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age less than 38 years at least 12 months of infertility women with unexplained infertility Exclusion Criteria: age more than or equals 38 years serum AMH level less than or equals 1 ng/ml patients of anticoagulant therapy immune-compromised patients patients with contraindications to low molecular weight heparin positive immunological markers patients with other than unexplained infertility male factor infertility refusal of participation patients with unexpected poor or over response during induction of ovulation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mostafa F Gomaa, MD
    Organizational Affiliation
    Ain Shams University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effect of LMWH on ICSI in Patients With Unexplained Infertility and Negative Immunological Markers

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