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

Sponsor

Faculdade de Medicina do ABC (Other)

Overall Status

Completed

CT.gov ID

NCT05225155

Collaborator

(none)

104

Enrollment

Location

54.9

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Retrospective study in order to verify outcomes in patients who had been submitted to assisted reproduction. Some of them had thrombophilia, and part were treated with enoxaparin initiated at the day of embryo transfer, and the other part not. Women without thrombophilia were the control group.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female Thrombophilia Fertilization in Vitro	Drug: Enoxaparin

Detailed Description

A retrospective study was carried out in order to verify outcomes in 104 patients who had been submitted to assisted reproduction. Women without thrombophilia were included as controls (n=20), while women with thrombophilia had either been treated with 40 mg daily enoxaparin (Treated Thrombophilia group), initiated at the day of embryo transfer, up to week 36 of

Study Design

Study Type:

Observational

Actual Enrollment :

104 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Feb 2, 2015

Actual Primary Completion Date :

Nov 30, 2015

Actual Study Completion Date :

Aug 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Control Women without thrombophilia, submitted to in vitro fertilization techniques
Untreated Thrombophilia Women with laboratorial thrombophilia, submitted to in vitro fertilization techniques, without treatment with enoxaparin
Treated Thrombophilia Women with laboratorial thrombophilia, submitted to in vitro fertilization techniques, and treated with enoxaparin	Drug: Enoxaparin Women with thrombophilia had been treated with 40 mg daily enoxaparin (Treated Thrombophilia group), initiated at the day of embryo transfer, up to week 36 of gestation

Arm

Intervention/Treatment

Control

Women without thrombophilia, submitted to in vitro fertilization techniques

Untreated Thrombophilia

Women with laboratorial thrombophilia, submitted to in vitro fertilization techniques, without treatment with enoxaparin

Treated Thrombophilia

Women with laboratorial thrombophilia, submitted to in vitro fertilization techniques, and treated with enoxaparin

Drug: Enoxaparin

Women with thrombophilia had been treated with 40 mg daily enoxaparin (Treated Thrombophilia group), initiated at the day of embryo transfer, up to week 36 of gestation

Outcome Measures

Primary Outcome Measures

Fetal hearbeat [Day 28]
A transvaginal ultrasound was performed for detection of fetal heartbeat
Ongoing pregnancy [Week 12]
Ongoing pregnancy was detected by ultrasound at twelve weeks
Live birth [Week 36]
Live birth was considered delivery that resulted in at least one live born neonate