Effect of Prophylatic Use of Enoxaparin in Women Undergoing in Vitro Fertilization Treatment

Study Overview
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Brief Summary
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Retrospective study designed to evaluate outcomes in patients undergoing assisted reproduction. Some of them had thrombophilia, and part of them was treated with enoxaparin, started on the day of embryo transfer, and the other part not. Women without thrombophilia formed the control group.

Detailed Description
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A retrospective study was performed to evaluate the results in 104 patients undergoing to assisted reproduction. Women without thrombophilia were included as controls (n=20), while women with thrombophilia were either treated with 40 mg daily of enoxaparin (treated group, n=54), initiated on the day of embryo transfer, and continued to the week 36 of gestation, or did not receive this medication (untreated group, n= 30).

Official Title
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Effect of Prophylatic Use of Enoxaparin in Women Undergoing in Vitro Fertilization Treatment

Conditions
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Infertility, Female, Thrombophilia, Fertilization in Vitro

Intervention / Treatment
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* Drug: Enoxaparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with female infertility or unexplained infertility Normal sperm analysis Exclusion Criteria: Women who did not agree with in vitro fertilization techniques
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Women without thrombophilia, submitted to in vitro fertilization techniques | |
| Untreated Thrombophilia<br>Women with laboratorial thrombophilia, submitted to in vitro fertilization techniques, without treatment with enoxaparin | |
| Treated Thrombophilia<br>Women with laboratorial thrombophilia, submitted to in vitro fertilization techniques, and treated with enoxaparin | Drug: Enoxaparin<br>* Women with thrombophilia were treated with 40 mg daily of enoxaparin (treated group), initiated on the day of embryo transfer, up to week 36 of gestation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with detectable fetal heartbeat | A transvaginal ultrasound was performed for detection of fetal heartbeat | Day 28 | 
| Number of participants with detectable ongoing pregnancy | Ongoing pregnancy was detected by ultrasound at twelve weeks | Week 12 | 
| Number of participants who delivered a live baby | Live birth was considered delivery that resulted in at least one live born neonate | Week 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with biochemical gestation detected | Serum beta-HCG detected 14 days after embryo transfer | Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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female infertility, thrombophilia, enoxaparin, abortion, in vitro fertilization, low molecular weight heparin