Lovenox With Aspirin in Thawed Blastocyst Transfer

NCT ID: NCT06133803

Last Updated: 2024-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-26

Study Completion Date

2024-12-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized trial comparing treatment to controls.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lovenox

Intervention Type DRUG

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

Aspirin

Intervention Type DRUG

Aspirin 81mg daily tablet.

Embryo transfer

Intervention Type PROCEDURE

Embryo transfer

Control Arm

This arm receives neither medication.

Group Type ACTIVE_COMPARATOR

Embryo transfer

Intervention Type PROCEDURE

Embryo transfer

Interventions

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Lovenox

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

Intervention Type DRUG

Aspirin

Aspirin 81mg daily tablet.

Intervention Type DRUG

Embryo transfer

Embryo transfer

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fertility Center of Las Vegas

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce Shapiro, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fertility Center of Las Vegas

Locations

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Fertility center of Las Vegas

Las Vegas, Nevada, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shironda Anderson

Role: CONTACT

702-254-1777

Facility Contacts

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Shironda Anderson, BA

Role: primary

702-254-1777 ext. 265

Other Identifiers

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FCLV 2023-2

Identifier Type: -

Identifier Source: org_study_id

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