Infertility, FemalePhase 4NCT06133803
Lovenox With Aspirin in Thawed Blastocyst Transfer
A Phase 4 study testing Lovenox, Aspirin and Embryo transfer in people with Infertility, Female, run by Fertility Center of Las Vegas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Lovenox, Aspirin and Embryo transfer
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2024to 15 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Fertility center of Las Vegas
Las Vegas, Nevada, 89117
Shironda Anderson, BA, 702-254-1777 ext. 265, Shironda@fertilitycenterlv.com
About this study
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.
Read the 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.
- Conditions
- Infertility, Female
- Being tested
- Lovenox, Aspirin, Embryo transfer
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LovenoxDrug
A low-molecular-weight heparin, 40mg daily injection.
AspirinDrug
Aspirin 81mg daily tablet.
Embryo transferProcedure or surgery
Embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | 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. Receives: Drug: Lovenox; Drug: Aspirin; Procedure: Embryo transfer |
| Control Arm | Active comparator | This arm receives neither medication. Receives: Procedure: Embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum hCG level
Serum hCG level
Measured: 5 days post transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start26 Jan 2024
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized trial comparing treatment to controls.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fertility Center of Las Vegas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Shapiro, MD, PhD, Principal investigator, Fertility Center of Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133803
- Sponsor's protocol ID
- FCLV 2023-2
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lovenox With Aspirin in Thawed Blastocyst Transfer
- ClinicalTrials.gov ID
- NCT06133803
- Acronym / sponsor ID
- FCLV 2023-2
- Conditions
- Infertility, Female
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Fertility Center of Las VegasIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized trial comparing treatment to controls.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Lovenox, Drug: Aspirin, Procedure: Embryo transferPatients 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 | Active comparator | Procedure: Embryo transferThis arm receives neither medication. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LovenoxA low-molecular-weight heparin, 40mg daily injection. | Drug | Treatment Arm |
| AspirinAspirin 81mg daily tablet. | Drug | Treatment Arm |
| Embryo transferEmbryo transfer | Procedure or surgery | Control Arm, Treatment Arm |
Primary outcome
Serum hCG level
Time frame: 5 days post transfer
Serum hCG level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Shapiro, MD, PhD principal investigator
Fertility Center of Las Vegas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lovenox, Aspirin and Embryo transfer in people with Infertility, Female, run by Fertility Center of Las Vegas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shironda Anderson (702-254-1777, shironda@fertilitycenterlv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum hCG level (time frame: 5 days post transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.