Lovenox With Aspirin in Thawed Blastocyst Transfer

Study Overview
=================
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.

Official Title
-----------------
Lovenox With Aspirin in Thawed Blastocyst Transfer

Conditions
-----------------
Infertility, Female

Intervention / Treatment
-----------------
* Drug: Lovenox
* Drug: Aspirin
* Procedure: Embryo transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized trial comparing treatment to controls.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>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<br>* A low-molecular-weight heparin, 40mg daily injection.<br>Drug: Aspirin<br>* Aspirin 81mg daily tablet.<br>Procedure: Embryo transfer<br>* Embryo transfer<br>|
| Active Comparator: Control Arm<br>This arm receives neither medication. | Procedure: Embryo transfer<br>* Embryo transfer<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum hCG level | Serum hCG level | 5 days post transfer |