Effect of Influenza Vaccination on Donor Egg Recipient Outcomes (DE-FluVac)

A Randomized Controlled Trial of the Effect of Influenza Vaccination on Implantation and Pregnancy Rates After Donor Egg Recipient In-Vitro Fertilization

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 as donor egg recipients.

Study Overview

• Status: Unknown
• Conditions: Infertility; Recurrent Miscarriage
• Intervention / Treatment: Biological: Influenza Vaccine; Other: Sterile Saline

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 donor egg recipient cycles 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.

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Center For Human Reproduction

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• All women preparing to undergo an oocyte donor recipient cycle

  1. Women will only be allowed to participate in one treatment cycle
  2. Willingness to have an influenza vaccination
  3. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Influenza Vaccine; O.5 mL single dose influenza vaccine suspension administered intramuscularly	Biological: 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.; Other Names: Seqirus afluria 2016-2017 formula
Placebo Comparator: Saline Injection; O.5 ml of sterile Saline administered intramuscularly	Other: Sterile Saline; 0.5 mL of sterile Saline administered im; Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Pregnancy	Intrauterine pregnancy with positive evidence of fetal heart beat	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implantation Rate	Number of clinical pregnancies per number of embryos transferred	8 weeks
Evidence of immune activation	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: Center for Human Reproduction
• Collaborators: Foundation for Human Reproduction
• 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): January 19, 2017
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: October 26, 2016
• First Posted (Estimate): October 27, 2016

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 15, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Immunology; Pregnancy; Implantation Rate; Fertilization in Vitro; Oocyte donor egg recipient
• Additional Relevant MeSH Terms: Pregnancy Complications; Infertility; Abortion, Spontaneous; Abortion, Habitual
• Other Study ID Numbers: 0627201601-DonorEgg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We do not plan to share individual participant data (IPD)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No