What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for infertility include ovulation induction with medications like clomiphene citrate and gonadotropins, intrauterine insemination (IUI), and in vitro fertilization (IVF). Side effects of these treatments can include ovarian hyperstimulation syndrome (OHSS), multiple pregnancies, and mood swings. Treatments that stimulate the immune system, such as intravenous immunoglobulin (IVIG), are less common and can have side effects like transmission of bloodborne pathogens and allergic reactions. While influenza vaccination is not a standard infertility treatment, it is generally safe with mild side effects such as soreness at the injection site and mild fever.

What prior FDA approvals exist?

The FDA has approved several treatments for infertility, including hormonal therapies like clomiphene citrate and gonadotropins, which stimulate ovulation. Additionally, assisted reproductive technologies such as in vitro fertilization (IVF) are widely used. While specific immunotherapy treatments for infertility are not broadly approved, there has been research into using intravenous immunoglobulin (IVIG) and paternal lymphocyte immunotherapy for recurrent pregnancy loss and unexplained infertility. These treatments aim to modulate the immune response, similar to how vaccines stimulate the immune system, but they are not yet standard practice and require further validation.

What other types of research exist?

Promising novel alternatives for infertility patients considering treatment in 2024 include acupuncture, low-dose aspirin, and granulocyte-colony stimulating factor (G-CSF) administration. These treatments have shown potential in improving pregnancy rates and live birth outcomes. Additionally, lifestyle changes and surgical interventions like varicocele repair may also be considered to enhance fertility.

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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

Drug Has Already Been Approved

Pivotal Trial

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

Select...

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:

Select...

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 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)

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

Chills

Nausea

Fever

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Needle- Free

Needle and Syringe

Awards & Highlights

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.

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

~16660

0 / 4Eligibility criteria met

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.