Combining Lovenox and Aspirin for Thawed Embryo Transfer

Lovenox With Aspirin in Thawed Blastocyst Transfer

This study is testing if combining Lovenox and aspirin can help women aged 18-42 have more successful pregnancies after transferring thawed embryos.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years to 42 Years
• Sex: Female
• Sponsor: Fertility Center of Las Vegas (industry)
• Locations: 1 site (Las Vegas, Nevada)
• Trial ID: NCT06133803 on ClinicalTrials.gov

What this trial studies

This prospective randomized trial aims to evaluate the effectiveness of combining aspirin with low-molecular weight heparin (Lovenox) in improving success rates for women undergoing thawed blastocyst transfers. Participants will be divided into two groups: one receiving the combination of medications and the other following the standard protocol without these treatments. The study will include women aged 18-42 with frozen embryos or oocytes, allowing for the use of pre-implantation genetically tested blastocysts. The goal is to determine if these medications can enhance the chances of successful pregnancy outcomes.

Who should consider this trial

Good fit: Ideal candidates are females aged 18-42 seeking embryo transfer with frozen embryos or oocytes.

Not a fit: Patients who are currently pregnant, under 18, or have certain medical conditions such as bleeding disorders will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve pregnancy success rates for women undergoing embryo transfers.

How similar studies have performed: While the combination of these medications has been explored in other contexts, this specific approach in thawed blastocyst transfer is relatively novel.

Eligibility criteria

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.

Where this trial is running

Las Vegas, Nevada

• Fertility center of Las Vegas — Las Vegas, Nevada, United States (RECRUITING)

Study contacts

• Principal investigator: Bruce Shapiro, MD, PhD — Fertility Center of Las Vegas
• Study coordinator: Shironda Anderson

Conditions: Infertility, Female