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

Completed

• Conditions: Fertilization in Vitro; Infertility, Female; Thrombophilia
• Interventions: Drug: Enoxaparin

• Registration Number: NCT05225155
• Lead Sponsor: Faculdade de Medicina do ABC

Brief Summary

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

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).

Study Timeline

• Study Start: 2015-02-02
• Primary Completion: 2015-11-30
• Study Completion: 2019-08-31
• Study First Submitted: 2022-01-25
• Study First Submitted QC: 2022-01-25
• Study First Posted: 2022-02-04
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-07
• Last Update Posted: 2022-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

Inclusion Criteria

• Women with female infertility or unexplained infertility
• Normal sperm analysis

Exclusion Criteria

• Women who did not agree with in vitro fertilization techniques

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treated Thrombophilia	Enoxaparin	Women with laboratorial thrombophilia, submitted to in vitro fertilization techniques, and treated with enoxaparin

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of participants with biochemical gestation detected	Day 14	Serum beta-HCG detected 14 days after embryo transfer

Trial Locations

Locations (1)

Assistencia Materno Infantil Lambert; 🇧🇷 Santo Andre, SP, Brazil