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Completed

NCT Number: NCT05225155

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

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.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fertilization in Vitro Genital Diseases Genital Diseases, Female Hematologic Diseases Hemic and Lymphatic Diseases Infertility Thrombophilia Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Assistencia Materno Infantil Lambert

Santo André, São Paulo, 09041000, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Women who did not agree with in vitro fertilization techniques

Treatment and study plan

Enoxaparin

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

Primary outcomes

  1. Number of participants with detectable fetal heartbeat

    Time frame: Day 28

    A transvaginal ultrasound was performed for detection of fetal heartbeat

  2. Number of participants with detectable ongoing pregnancy

    Time frame: Week 12

    Ongoing pregnancy was detected by ultrasound at twelve weeks

  3. Number of participants who delivered a live baby

    Time frame: Week 36

    Live birth was considered delivery that resulted in at least one live born neonate

Secondary outcomes

  1. Number of participants with biochemical gestation detected

    Time frame: Day 14

    Serum beta-HCG detected 14 days after embryo transfer

Sponsors and collaborators

Lead sponsor

Faculdade de Medicina do ABC

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2019
First posted
Feb 4, 2022
Registry last updated
Sep 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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