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Vaccine

Influenza Vaccine for Infertility (IVF-FluVac Trial)

Phase 4
Waitlist Available
Led By David H Barad, MD, MS
Research Sponsored by Center for Human Reproduction
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women will only be allowed to participate in one treatment cycle
Be between 18 and 65 years old
Must not have
Previous diagnosis of unfavorable endometrial development
Unwillingness to have a flu vaccination
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 to 21 days (at time of egg retrieval)
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
The study aims to see if getting a flu shot affects pregnancy rates in women going through IVF. Participants will be randomly assigned either the influenza vaccine or sterile saline as a control group before starting their IVF treatment.
What are the potential side effects?
Potential side effects from the influenza vaccine may include soreness at injection site, mild fever, muscle aches, and fatigue. The sterile saline is unlikely to cause any side effects beyond possible discomfort at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman and I understand I can only participate in one treatment cycle.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I was diagnosed with a condition affecting my womb lining.
Select...
I am not willing to get a flu shot.
Select...
I have a uterine condition that affects the inside of my uterus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 to 21 days (at time of egg retrieval)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 to 21 days (at time of egg retrieval) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical Pregnancy
Secondary study objectives
Evidence of immune activation
Implantation Rate

Side effects data

From 2015 Phase 4 trial • 985 Patients • NCT02290691
64%
Tenderness
48%
Pain
35%
Redness
29%
Swelling
24%
Itching
20%
Muscle Ache
15%
Headache
12%
Fatigue
10%
Bruising
5%
Chills
4%
Nausea
1%
Fever
1%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Needle- Free
Needle and Syringe

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Influenza VaccineExperimental Treatment1 Intervention
O.5 mL single dose influenza vaccine suspension administered intramuscularly
Group II: Saline InjectionPlacebo Group1 Intervention
O.5 ml of sterile Saline administered intramuscularly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Influenza Vaccine
2022
Completed Phase 4
~16570

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common infertility treatments include ovulation induction agents like clomiphene citrate and letrozole, which stimulate the ovaries to produce eggs by modulating hormone levels. Assisted reproductive technologies (ART) such as in vitro fertilization (IVF) involve retrieving eggs and fertilizing them outside the body before implanting the embryo in the uterus. Hormonal therapies, including gonadotropins, directly stimulate the ovaries to produce multiple follicles. These treatments are crucial for infertility patients as they enhance the chances of conception by addressing specific reproductive challenges, much like how influenza vaccination boosts the immune system to fight off infections.
Immunogenicity of influenza vaccine in elderly people: a systematic review and meta-analysis of randomized controlled trials, and its association with real-world effectiveness.Double dose vs. standard dose influenza vaccination in patients with heart failure: a pilot study.

Find a Location

Who is running the clinical trial?

Center for Human ReproductionLead Sponsor
13 Previous Clinical Trials
929 Total Patients Enrolled
10 Trials studying Infertility
739 Patients Enrolled for Infertility
Foundation for Human ReproductionUNKNOWN
1 Previous Clinical Trials
126 Total Patients Enrolled
1 Trials studying Infertility
126 Patients Enrolled for Infertility
David H Barad, MD, MSPrincipal InvestigatorDirector of Assisted Reproductive Technology
4 Previous Clinical Trials
447 Total Patients Enrolled
4 Trials studying Infertility
447 Patients Enrolled for Infertility

Media Library

Influenza Vaccine (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT02947217 — Phase 4
Infertility Research Study Groups: Influenza Vaccine, Saline Injection
Infertility Clinical Trial 2023: Influenza Vaccine Highlights & Side Effects. Trial Name: NCT02947217 — Phase 4
Influenza Vaccine (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02947217 — Phase 4
~27 spots leftby Sep 2025
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