Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861105
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
Mostafa Fouad Gomaa, Ain Shams University

Tracking Information
First Submitted Date  ICMJE August 5, 2016
First Posted Date  ICMJE August 10, 2016
Last Update Posted Date August 12, 2016
Study Start Date  ICMJE January 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2016)
Live birth Rate [ Time Frame: at delivery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2016)
  • Clinical Pregnancy Rate [ Time Frame: at 7 weeks of gestation ]
  • Biochemical Pregnancy Rate [ Time Frame: 14 days after embryo transfer ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of LMWH on ICSI in Patients With Unexplained Infertility and Negative Immunological Markers
Official Title  ICMJE The Effect of LMWH on ICSI Outcome in Patients With Unexplained Infertility and Negative Immunological Markers; a Randomized Controlled Trial
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:

  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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Unexplained Infertility
Intervention  ICMJE
  • 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
  • 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 Name: 0.9% sodium chloride solution
Study Arms  ICMJE
  • 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
    Intervention: Drug: LMWH
  • 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
    Intervention: Other: 0.9% saline solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2016)
716
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 38 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02861105
Other Study ID Numbers  ICMJE ASU-OG-333
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mostafa Fouad Gomaa, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mostafa F Gomaa, MD Ain Shams University
PRS Account Ain Shams University
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP