Lovenox With Aspirin in Thawed Blastocyst Transfer

Infertility, Female Clinical Trial

Official title:

Lovenox With Aspirin in Thawed Blastocyst Transfer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06133803
• Other study ID #: FCLV 2023-2
• Status: Recruiting
• Phase: Phase 4
• Start date: January 26, 2024
• Est. completion date: December 15, 2024

Study information

• Verified date: November 2023
• Source: Fertility Center of Las Vegas
• Contact: Shironda Anderson
• Phone: 702-254-1777
• Email: shironda[@]fertilitycenterlv.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Drug:
• Lovenox
A low-molecular-weight heparin, 40mg daily injection.
• Aspirin
Aspirin 81mg daily tablet.

Procedure:
• Embryo transfer
Embryo transfer

Locations

Country	Name	City	State
United States	Fertility center of Las Vegas	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
Fertility Center of Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum hCG level	Serum hCG level	5 days post transfer