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.

Study Overview

• Status: Completed
• Conditions: Thrombophilia; Infertility, Female; Fertilization in Vitro
• Intervention / Treatment: Drug: Enoxaparin

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 Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Santo Andre, SP, Brazil, 09041000
      • Assistencia Materno Infantil Lambert

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All included patients underwent in vitro fertilization (IVF) treatment with intracytoplasmic sperm injection (ICSI). Patients were initially submitted to controlled ovarian hyperstimulation under a short protocol with gonadotropins and GnRH antagonist. Women with laboratorial thrombophilia could be treated or not with enoxaparin according to her physician's decision. Women without detectable thrombophilia formed the control group.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Women without thrombophilia, submitted to in vitro fertilization techniques
Untreated Thrombophilia; Women with laboratorial thrombophilia, submitted to in vitro fertilization techniques, without treatment with enoxaparin
Treated Thrombophilia; Women with laboratorial thrombophilia, submitted to in vitro fertilization techniques, and treated with enoxaparin	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with detectable fetal heartbeat	A transvaginal ultrasound was performed for detection of fetal heartbeat	Day 28
Number of participants with detectable ongoing pregnancy	Ongoing pregnancy was detected by ultrasound at twelve weeks	Week 12
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with biochemical gestation detected	Serum beta-HCG detected 14 days after embryo transfer	Day 14

Collaborators and Investigators

• Sponsor: Faculdade de Medicina do ABC
• Investigators: Study Director: Luciano M Pompei, Faculdade de Medicina do ABC

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2015
• Primary Completion (Actual): November 30, 2015
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: abortion; low molecular weight heparin; enoxaparin; in vitro fertilization; thrombophilia; female infertility
• Additional Relevant MeSH Terms: Hematologic Diseases; Infertility; Infertility, Female; Thrombophilia; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin
• Other Study ID Numbers: 41006620.0.0000.0082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The IPD sharing was not approved yet by our ethical committee board

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No