Lovenox With Aspirin in Thawed Blastocyst Transfer

Sponsor

Fertility Center of Las Vegas (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06133803

Collaborator

(none)

130

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female	Drug: Lovenox Drug: Aspirin Procedure: Embryo transfer	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized trial comparing treatment to controls.Randomized trial comparing treatment to controls.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Lovenox With Aspirin in Thawed Blastocyst Transfer

Anticipated Study Start Date :

Nov 15, 2023

Anticipated Primary Completion Date :

Dec 15, 2024

Anticipated Study Completion Date :

Dec 15, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Serum hCG level [5 days post transfer]
Serum hCG level

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 42 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fertility center of Las Vegas	Las Vegas	Nevada	United States	89117

Sponsors and Collaborators

Fertility Center of Las Vegas

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fertility Center of Las Vegas

ClinicalTrials.gov Identifier:

NCT06133803

Other Study ID Numbers:

FCLV 2023-2

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2023