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

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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

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
Unexplained Infertility Drug: LMWH Other: 0.9% saline solution 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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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 Name: 0.9% sodium chloride solution




Primary Outcome Measures :
  1. Live birth Rate [ Time Frame: at delivery ]

Secondary Outcome Measures :
  1. Clinical Pregnancy Rate [ Time Frame: at 7 weeks of gestation ]
  2. Biochemical Pregnancy Rate [ Time Frame: 14 days after embryo transfer ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 38 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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): NCT02861105


Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Mostafa F Gomaa, MD Ain Shams University
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Responsible Party: Mostafa Fouad Gomaa, Professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT02861105    
Other Study ID Numbers: ASU-OG-333
First Posted: August 10, 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
Additional relevant MeSH terms:
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Infertility
Enoxaparin
Pharmaceutical Solutions
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action