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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05225155
• Other study ID #: 41006620.0.0000.0082
• Status: Completed
• Start date: February 2, 2015
• Est. completion date: August 31, 2019

Study information

• Verified date: September 2022
• Source: Faculdade de Medicina do ABC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: August 31, 2019
• Est. primary completion date: November 30, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Women with female infertility or unexplained infertility

• Normal sperm analysis

Exclusion Criteria:

• Women who did not agree with in vitro fertilization techniques

Related Conditions & MeSH terms

• Fertilization in Vitro
• Infertility
• Infertility, Female
• Thrombophilia

Intervention

Drug:
• Enoxaparin
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

Locations

Country	Name	City	State
Brazil	Assistencia Materno Infantil Lambert	Santo Andre	SP

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Medicina do ABC

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with detectable fetal heartbeat	A transvaginal ultrasound was performed for detection of fetal heartbeat	Day 28
Primary	Number of participants with detectable ongoing pregnancy	Ongoing pregnancy was detected by ultrasound at twelve weeks	Week 12
Primary	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	Number of participants with biochemical gestation detected	Serum beta-HCG detected 14 days after embryo transfer	Day 14