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

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT02861105
Collaborator
(none)
716
Enrollment
2
Arms
14
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Inclusion criteria:

  1. patients undergoing 1st trial ICSI

  2. unexplained infertility

  3. negative immunological markers including ACL abs, LAC, ANA, ATA, AnitdsDNA

Exclusion criteria:

  1. previous IVF/ICSI

  2. Any cause of infertility

  3. Suspected and/or unexpected poor response during ovulation induction

  4. positive immunological markers

  5. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
716 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Effect of LMWH on ICSI Outcome in Patients With Unexplained Infertility and Negative Immunological Markers; a Randomized Controlled Trial
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: LMWH supplementation

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

Drug: LMWH
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.
Other Names:
  • Clexane
  • Enoxaparin

    		•
    Placebo Comparator: 0.9% saline solution

    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

    Other: 0.9% saline solution
    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.
    Other Names:
  • 0.9% sodium chloride solution

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Live birth Rate [at delivery]

    Secondary Outcome Measures

    1. Clinical Pregnancy Rate [at 7 weeks of gestation]

    2. Biochemical Pregnancy Rate [14 days after embryo transfer]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 38 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Principal Investigator: Mostafa F Gomaa, MD, Ain Shams University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mostafa Fouad Gomaa, Professor, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT02861105
    Other Study ID Numbers:
    • ASU-OG-333
    First Posted:
    Aug 10, 2016
    Last Update Posted:
    Aug 12, 2016
    Last Verified:
    Aug 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Infertility
    Enoxaparin
    Pharmaceutical Solutions

    Study Results

    No Results Posted as of Aug 12, 2016