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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of LMWH on ICSI Outcome in Patients With Unexplained Infertility and Negative Immunological Markers; a Randomized Controlled Trial

Conditions
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Unexplained Infertility

Intervention / Treatment
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* Drug: LMWH
* Other: 0.9% saline solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LMWH supplementation<br>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<br>* 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.<br>* Other names: Enoxaparin;|
| Placebo Comparator: 0.9% saline solution<br>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<br>* 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.<br>* Other names: 0.9% sodium chloride solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth Rate |  | at delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy Rate |  | at 7 weeks of gestation | 
| Biochemical Pregnancy Rate |  | 14 days after embryo transfer |