- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02947217
Effect of Influenza Vaccination on IVF Outcomes - IVF (IVF-FluVac)
A Randomized Controlled Trial of the Effect of Influenza Vaccination on Implantation and Pregnancy Rates After In-Vitro Fertilization
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Since 2004 flu vaccination has been recommended by American College of Obstetricians and Gynecologists (ACOG) Advisory Committee on Immunization Practices (ACIP) for all pregnant women during flu season, regardless of the trimester of pregnancy. Many studies have examined the safety of influenza vaccination and found benefits beyond the simple prevention of maternal infection including the reduction of still birth. Recently evidence has emerged that women who have received a flu vaccination were less likely to experience premature labor. The investigators hypothesize that some of the maternal benefits of influenza vaccination might be based on other than prevention of the flu, possibly secondary to the induction of immune system pathways that favor immunological tolerance. Induction of immune system pathways that favor immunological tolerance has long been considered a possible path to improved embryo implantation and reduce miscarriages, though the topic is still somewhat controversial.
Patients undergoing IVF will be randomized in two strata:
- History of recurrent miscarriage or implantation failure
- No history of recurrent miscarriage of implantation failure
Consenting patients will be randomized to receive either influenza vaccine or a saline placebo. Vaccination will occur 10 days before initiating anticipated menses or fertility treatment cycle start.
All patients will be receiving an offered a second injection at the time of negative pregnancy test or at the time of sign-out with a clinical pregnancy. The second injection will either be placebo or influenza vaccination depending on the original randomization. Patients and clinical staff will remain blinded to the original treatment assignment, except for the study coordinator and the single staff member assigned to administer the injection.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Center For Human Reproduction
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All women preparing to undergo an IVF cycle
- Women will only be allowed to participate in one treatment cycle
- Willingness to have an influenza vaccination
- Signed informed consent
Exclusion Criteria:
- Any contraindication for flu vaccination
- Unwillingness to have a flu vaccination
- Unwillingness to sign informed consent
- Previous diagnosis of unfavorable endometrial development
- Unresolved uterine condition that significantly compromises the endometrial cavity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Influenza Vaccine
O.5 mL single dose influenza vaccine suspension administered intramuscularly
|
Inactivated influenza vaccine indicated for immunization against disease caused by influenza virus subtype A and type B present in the vaccine.
Approved for use in persons 5 years of age and older.
Single Dose prefilled 0.5 ml syringe.
Other Names:
|
Placebo Comparator: Saline Injection
O.5 ml of sterile Saline administered intramuscularly
|
0.5 mL of sterile Saline administered im
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Pregnancy
Time Frame: 8 weeks
|
Intrauterine pregnancy with positive evidence of fetal heart beat
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implantation Rate
Time Frame: 8 weeks
|
Number of clinical pregnancies per number of embryos transferred
|
8 weeks
|
Evidence of immune activation
Time Frame: 14 to 21 days (at time of egg retrieval)
|
Evidence of peripheral markers of immune pathways activated by the influenza vaccine
|
14 to 21 days (at time of egg retrieval)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David H Barad, MD, MS, Director of Assisted Reproductive Technology
- Study Director: Norbert Gleicher, MD, Medical Director
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06272016-01 - IVF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infertility
-
Assuta Hospital SystemsMaccabi Healthcare Services, IsraelCompletedInfertility, Female Infertility, Male InfertilityIsrael
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedPregnancy | Male Infertility | Female InfertilityNetherlands
-
Sapientiae InstituteTerminated
-
Esraa Gamal AhmedAin Shams Maternity HospitalUnknownUnexplained Female Infertility
-
King's College LondonNot yet recruitingInfertility | Infertility, Female | Infertility Unexplained | Infertility of Tubal Origin
-
Gazi UniversityCompletedMale Infertility | Unexplained Infertility
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMale Infertility, AzoospermiaUnited States
-
Wake Forest University Health SciencesWithdrawnUterine Diseases | Endometriosis | Infertility Unexplained | Endometrial Diseases | Infertility; Female, NonimplantationUnited States
-
Pacific Fertility CenterTerminatedPrimary Female Infertility | Secondary Female Infertility
-
Istanbul University - Cerrahpasa (IUC)RecruitingInfertility | Sexual Dysfunction | Infertility, Male | Nurse's Role | Sexuality | Infertility; FemaleTurkey
Clinical Trials on Influenza Vaccine
-
Novartis VaccinesCompleted
-
University of RochesterNational Institutes of Health (NIH)Withdrawn2009 H1N1 InfluenzaUnited States
-
Emory UniversityRecruitingFollicular Lymphoma | Diffuse Large B-Cell Lymphoma | Mantle Cell Lymphoma | Chronic Lymphocytic Leukemia | Mature T-Cell and NK-Cell Non-Hodgkin LymphomaUnited States
-
Masonic Cancer Center, University of MinnesotaTerminatedHematologic Malignancy | Hematopoietic Stem Cell TransplantUnited States
-
Sinovac Biotech Co., LtdRecruitingA Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 MonthsSeasonal InfluenzaChina
-
Sinovac Biotech Co., LtdRecruitingSeasonal InfluenzaChina
-
Fluart Innovative Vaccine Ltd, HungaryCompleted
-
NovartisNovartis VaccinesCompletedInfluenza InfectionSwitzerland
-
Novartis VaccinesCompleted