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

NCT05225155 | Completed FDA Drug

• 1 other identifier: 41006620.0.0000.0082
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility, Female; Thrombophilia; Fertilization in Vitro

Keywords

female infertility; thrombophilia; enoxaparin; abortion; in vitro fertilization; low molecular weight heparin

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of participants with biochemical gestation detected

  Day 14

Study Arms (3)

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

Interventions

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

Treated Thrombophilia

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Women who did not agree with in vitro fertilization techniques

Sponsors & Collaborators

• Faculdade de Medicina do ABC: lead

Study Sites (1)

Assistencia Materno Infantil Lambert

Santo André, São Paulo, 09041000, Brazil

Location

MeSH Terms

Conditions

Infertility, Female; Thrombophilia

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Luciano M Pompei

  Faculdade de Medicina do ABC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Auxiliary Professor at Gynecology Department

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 4, 2022
• Study Start: February 2, 2015
• Primary Completion: November 30, 2015
• Study Completion: August 31, 2019
• Last Updated: September 10, 2022

Record last verified: 2022-09

Locations

BR (1)