Lovenox With Aspirin in Thawed Blastocyst Transfer

Phase 4

Recruiting

• Conditions: Infertility, Female
• Interventions: Drug: Lovenox; Drug: Aspirin; Procedure: Embryo transfer

• Registration Number: NCT06133803
• Lead Sponsor: Fertility Center of Las Vegas

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.

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 Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-10
• Study First Submitted QC: 2023-11-10
• Study First Posted: 2023-11-18
• Study Start: 2024-01-26
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Embryo transfer	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.
Control Arm	Embryo transfer	This arm receives neither medication.
Treatment Arm	Lovenox	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.
Treatment Arm	Aspirin	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.

Primary Outcome Measures

Name	Time	Method
Serum hCG level	5 days post transfer	Serum hCG level

Trial Locations

Locations (1)

Fertility center of Las Vegas; 🇺🇸 Las Vegas, Nevada, United States