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Lovenox + Aspirin for Infertility

Phase 4

Recruiting

Led By Bruce Shapiro, MD, PhD

Research Sponsored by Fertility Center of Las Vegas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female patient 18-42 years of age with frozen embryos or oocytes seeking embryo transfer

Be between 18 and 65 years old

Must not have

Minor (age<18 years)

Unable to provide informed consent in English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 days post transfer

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial will compare patients taking aspirin and heparin to those without to see if it improves results.

Who is the study for?

This trial is for women aged 18-42 who want to have a frozen embryo transfer, including those using donated embryos or eggs. It's open to patients with any history of IVF cycles. Women must not be currently pregnant, under 18, unable to consent in English, using a surrogate, or have certain medical conditions like bleeding disorders.

What is being tested?

The study is testing if Lovenox (a low-molecular weight heparin) combined with Aspirin can improve the success rates of thawed blastocyst transfers compared to standard protocols without these medications. Participants will be randomly assigned to either receive both drugs or none before their embryo transfer.

What are the potential side effects?

Possible side effects from Lovenox and Aspirin may include bleeding issues due to thinner blood, allergic reactions, and irritation at the injection site for Lovenox. The severity of side effects can vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged 18-42 with frozen embryos or eggs, seeking embryo transfer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I cannot give informed consent in English.

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I have a history of low platelets, bleeding disorders, or I regularly take blood thinners.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 days post transfer

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 days post transfer

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 days post transfer for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Serum hCG level

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment ArmExperimental Treatment3 Interventions

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 II: Control ArmActive Control1 Intervention

This arm receives neither medication.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lovenox

2012

Completed Phase 1

~180

Embryo transfer

2017