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

NCT ID: NCT05225155

Last Updated: 2022-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-02

Study Completion Date

2019-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility, Female Thrombophilia Fertilization in Vitro

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Women without thrombophilia, submitted to in vitro fertilization techniques

No interventions assigned to this group

Untreated Thrombophilia

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

No interventions assigned to this group

Treated Thrombophilia

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

Enoxaparin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Women who did not agree with in vitro fertilization techniques
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Faculdade de Medicina do ABC

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Luciano de Melo Pompei'

Auxiliary Professor at Gynecology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Luciano M Pompei

Role: STUDY_DIRECTOR

Faculdade de Medicina do ABC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assistencia Materno Infantil Lambert

Santo André, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

41006620.0.0000.0082

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Timing of VTE Prophylaxis in TBI
NCT03081169 WITHDRAWN PHASE4