Influenza Vaccine for Infertility
(IVF-FluVac Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing if a flu shot can help women undergoing IVF get pregnant. The study focuses on women who have had trouble with miscarriages or embryo implantation. Researchers think the flu shot might make the immune system more supportive of pregnancy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Is the influenza vaccine generally safe for humans?
Research shows that various influenza vaccines, including Flublok, Vaxigrip, Intanza, and Fluad, have been studied for safety in different groups, such as older adults and pregnant individuals. These studies generally found that the vaccines are safe, with some people experiencing mild side effects like soreness or mild reactions, but no major safety concerns were identified.12345
How does the influenza vaccine differ from other treatments for infertility?
The influenza vaccine, typically used to prevent the flu, is unique in this context as it is being explored for infertility, a condition with no standard vaccine treatment. Unlike conventional infertility treatments, this approach leverages the vaccine's ability to stimulate the immune system, which is not a typical mechanism used in fertility therapies.35678
Who Is on the Research Team?
David H Barad, MD, MS
Principal Investigator
Director of Assisted Reproductive Technology
Norbert Gleicher, MD
Principal Investigator
Medical Director
Are You a Good Fit for This Trial?
This trial is for women planning to undergo in vitro fertilization (IVF) who are willing and able to receive an influenza vaccination. They must consent to participate in only one treatment cycle. Women with a history of poor endometrial development, contraindications for flu shots, unresolved uterine conditions affecting the womb's lining, or unwillingness to consent are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Treatment
Participants receive either influenza vaccine or saline placebo 10 days before initiating fertility treatment cycle
Treatment
Participants undergo in vitro fertilization with monitoring for clinical pregnancy and immune activation
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a second injection at the time of negative pregnancy test or clinical pregnancy
What Are the Treatments Tested in This Trial?
Interventions
- Influenza Vaccine
Influenza Vaccine is already approved in United States, European Union for the following indications:
- Prevention of influenza A and B
- Prevention of influenza A and B
- Prevention of influenza A and B
- Prevention of influenza A and B
- Prevention of influenza A and B
- Prevention of influenza A and B in adults 65 years and older
- Prevention of influenza A and B in individuals 2-49 years old
- Prevention of influenza A and B
- Prevention of influenza A and B
- Prevention of influenza A and B
Find a Clinic Near You
Who Is Running the Clinical Trial?
Center for Human Reproduction
Lead Sponsor
Foundation for Human Reproduction
Collaborator