Vaccine

Influenza Vaccine for Infertility

Center For Human Reproduction, New York, NY

Influenza Vaccine +1 morePhase 4Waitlist AvailableLed by David H Barad, MD, MSResearch Sponsored by Center for Human Reproduction

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Be younger than 18 years old

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up14 to 21 days (at time of egg retrieval)

Awards & highlights

All Individual Drugs Already Approved

Drug Has Already Been Approved

Pivotal Trial

Study Summary

This trial will test whether the flu vaccine increases the chances of pregnancy for women undergoing IVF.

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

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 • 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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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 A virus A/California/7/2009 X-181 (H1N1) hemagglutinin antigen (propiolactone inactivated)

FDA approved

Do I qualify?Apply below to find out

Find a site

Who is running the clinical trial?

Center for Human ReproductionLead Sponsor

13 Previous Clinical Trials

935 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 Investigator

Director of Assisted Reproductive Technology

4 Previous Clinical Trials

447 Total Patients Enrolled

4 Trials studying Infertility

447 Patients Enrolled for Infertility

Norbert Gleicher, MDStudy Director

Medical Director

8 Previous Clinical Trials

593 Total Patients Enrolled

5 Trials studying Infertility

482 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the Influenza Vaccine a reliable safeguard for individuals?

"Data collected from Phase 4 trials indicates that Influenza Vaccine is safe and thus merits a score of 3."

Answered by AI

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