Effect of Influenza Vaccination on IVF Outcomes - IVF

NCT ID: NCT02947217

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-19
• Study Completion Date: 2024-12-31

Brief Summary

In this study the investigators propose a randomized controlled trial to evaluate the effect of influenza vaccination on clinical pregnancy rates among women undergoing in vitro fertilization.

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:

1. History of recurrent miscarriage or implantation failure

2. 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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Influenza Vaccine

O.5 mL single dose influenza vaccine suspension administered intramuscularly

Group Type: EXPERIMENTAL

Influenza Vaccine

Intervention Type: BIOLOGICAL

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.

Saline Injection

O.5 ml of sterile Saline administered intramuscularly

Group Type: PLACEBO_COMPARATOR

Sterile Saline

Intervention Type: OTHER

0.5 mL of sterile Saline administered im

Interventions

Influenza Vaccine

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.

Intervention Type: BIOLOGICAL

Sterile Saline

0.5 mL of sterile Saline administered im

Intervention Type: OTHER

Other Intervention Names

Seqirus afluria 2016-2017 formula; Saline

Eligibility Criteria

Inclusion Criteria

1. All women preparing to undergo an IVF cycle

2. Women will only be allowed to participate in one treatment cycle

3. Willingness to have an influenza vaccination

4. Signed informed consent

Exclusion Criteria

1. Any contraindication for flu vaccination

2. Unwillingness to have a flu vaccination

3. Unwillingness to sign informed consent

4. Previous diagnosis of unfavorable endometrial development

5. Unresolved uterine condition that significantly compromises the endometrial cavity

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Foundation for Human Reproduction

UNKNOWN

Sponsor Role: collaborator

Center for Human Reproduction

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David H Barad, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Director of Assisted Reproductive Technology

Norbert Gleicher, MD

Role: STUDY_DIRECTOR

Medical Director

Locations

Center For Human Reproduction

New York, New York, United States

Countries

United States

Other Identifiers

06272016-01 - IVF

Identifier Type: -

Identifier Source: org_study_id