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
About this trial
This is an interventional treatment trial for Unexplained Infertility
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
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
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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