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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 to 21 days (at time of egg retrieval)
Awards & highlights
IVF-FluVac Trial Summary
This trial will test whether the flu vaccine increases the chances of pregnancy for women undergoing IVF.
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.Check my eligibility
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.See study design
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.
IVF-FluVac Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman and I understand I can only participate in one treatment cycle.
IVF-FluVac Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 to 21 days (at time of egg retrieval)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 to 21 days (at time of egg retrieval)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Pregnancy
Secondary outcome measures
Evidence of immune activation
Implantation Rate
Side effects data
From 2015 Phase 4 trial • 985 Patients • NCT0229069164%
Tenderness
48%
Pain
35%
Redness
29%
Swelling
24%
Itching
20%
Muscle Ache
15%
Headache
12%
Fatigue
10%
Bruising
5%
Chills
4%
Nausea
1%
Vomiting
1%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Needle- Free
Needle and Syringe
IVF-FluVac 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
2010
Completed Phase 4
~6900
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
Norbert Gleicher, MDStudy DirectorMedical Director
8 Previous Clinical Trials
587 Total Patients Enrolled
5 Trials studying Infertility
482 Patients Enrolled for Infertility
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with a condition affecting my womb lining.I am not willing to get a flu shot.I have a uterine condition that affects the inside of my uterus.You must be willing to get a flu shot.I am a woman and I understand I can only participate in one treatment cycle.You cannot receive a flu vaccine for medical reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Influenza Vaccine
- Group 2: Saline Injection
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it permissible for individuals over 45 to participate in this research?
"The criteria for entry into this trial necessitates that applicants are between 21 and 38 years of age. Alternatively, 14 research studies exist for individuals below the legal age limit while 36 trials encompass persons above 65."
Answered by AI
How many participants have been enrolled in this trial thus far?
"At this moment, the trial is not enrolling patients. Initially posted on January 19th 2017 and most recently modified March 8th 2022, individuals seeking to participate in clinical studies may wish to consider the 249 trials pertaining to infertility or two active influenza vaccine tests instead."
Answered by AI
Are there any other investigations in which the Influenza Vaccine has been utilized?
"Currently, two trials for Influenza Vaccine are in progress, neither of which have advanced to Phase 3 yet. These studies are taking place at multiple medical centres such as Bethesda, Maryland and another undisclosed location."
Answered by AI
Are there still opportunities for enrolment into this experiment?
"This specific study, which was first announced in January 19th 2017 has ceased recruitment. Clinicaltrials.gov reveals that the last edit to this trial occurred on March 8th 2022. Fortunately, there are an additional 251 clinical trials actively searching for participants right now."
Answered by AI
Is it possible to participate in this medical trial at the present time?
"Candidates aged 21-38 who have been diagnosed with infertility are eligible to participate in this medical trial. A total of 238 participants will be accepted into the study."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
New York
Alabama
Other
How old are they?
18 - 65
What site did they apply to?
Center For Human Reproduction
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
Looking for costs, is IVF done with you, and what is the support given?
PatientReceived no prior treatments
Why did patients apply to this trial?
Recent research and studies
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