Lovenox With Aspirin in Thawed Blastocyst Transfer

February 20, 2024 updated by: Fertility Center of Las Vegas
This prospective randomized trial will compare outcomes in patients receiving aspirin in combination with a low-molecular weight heparin and those under this center's standard protocol receiving neither medication, in order to determine if these medications may improve success rates.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective randomized trial will compare outcomes in patients receiving aspirin (81mg daily) in combination with a low-molecular weight heparin (LMWH) (enoxaparin (Lovenox®), 40mg daily subcutaneous injection) and those under this center's standard protocol receiving neither medication, in order to determine if these medications may improve success rates.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Female patient 18-42 years of age with frozen embryos or oocytes seeking embryo transfer.
  2. Use of pre-implantation genetically tested (PGT) blastocysts is allowed but not required.
  3. Use of donated embryos or embryos derived from donated eggs is allowed.
  4. Prior history of successful, failed, and/or canceled IVF cycles are allowed.

Exclusion Criteria:

  1. Minor (age<18 years).
  2. Currently pregnant.
  3. Unable to provide informed consent in English.
  4. Gestational carrier or "surrogate".
  5. Blastocysts frozen at another center (Oocytes frozen elsewhere is acceptable).
  6. Subject intending or having "natural cycle" thaw transfer with an active ovarian follicle present.
  7. Currently participating in any other research study.
  8. Subject already had an embryo transfer under this study.
  9. History of thrombocytopenia (reduced platelets), bleeding disorders, or routinely using anti-coagulant medication.
  10. Hypersensitivity to aspirin, heparin, or benzyl alcohol.
  11. Anyone for whom the physician assesses this protocol is inappropriate or unsafe.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
Patients randomized to receive aspirin and Lovenox will begin taking one "low dose" 81mg aspirin and one 40mg injection of Lovenox daily, on the day of progesterone start.
Drug: Lovenox
A low-molecular-weight heparin, 40mg daily injection.
Drug: Aspirin
Aspirin 81mg daily tablet.
Procedure: Embryo transfer
Embryo transfer
Active Comparator: Control Arm
This arm receives neither medication.
Procedure: Embryo transfer
Embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum hCG level
Time Frame: 5 days post transfer
Serum hCG level
5 days post transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fertility Center of Las Vegas

Investigators

  • Principal Investigator: Bruce Shapiro, MD, PhD, Fertility Center of Las Vegas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2024

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

November 10, 2023

First Submitted That Met QC Criteria

November 10, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FCLV 2023-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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