NCT06133803

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2024

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 26, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

February 21, 2024

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

November 10, 2023

Last Update Submit

February 20, 2024

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

  • Serum hCG level

    Serum hCG level

    5 days post transfer

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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: LovenoxDrug: AspirinProcedure: Embryo transfer

Control Arm

ACTIVE COMPARATOR

This arm receives neither medication.

Procedure: Embryo transfer

Interventions

LovenoxDRUG

A low-molecular-weight heparin, 40mg daily injection.

Treatment Arm
AspirinDRUG

Aspirin 81mg daily tablet.

Treatment Arm
Embryo transferPROCEDURE

Embryo transfer

Control ArmTreatment Arm

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale seeking pregnancy.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility center of Las Vegas

Las Vegas, Nevada, 89117, United States

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Interventions

EnoxaparinAspirinEmbryo Transfer

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydratesSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Bruce Shapiro, MD, PhD

    Fertility Center of Las Vegas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shironda Anderson

CONTACT

702-254-1777shironda@fertilitycenterlv.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized trial comparing treatment to controls.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2023

First Posted

November 18, 2023

Study Start

January 26, 2024

Primary Completion

December 15, 2024

Study Completion

December 15, 2024

Last Updated

February 21, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)