Effect of Influenza Vaccination on Donor Egg Recipient Outcomes

Status Enrolling by invitation

Clinical Trial 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 as donor egg recipients.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02946177
Study type	Interventional
Source	Center for Human Reproduction
Contact
Status	Enrolling by invitation
Phase	Phase 4
Start date	January 19, 2017
Completion date	December 31, 2021

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms