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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05225155
Other study ID # 41006620.0.0000.0082
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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