Effect of Influenza Vaccination on Donor Egg Recipient Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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.

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

Conditions
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Infertility, Recurrent Miscarriage

Intervention / Treatment
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* Biological: Influenza Vaccine
* Other: Sterile Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All women preparing to undergo an oocyte donor recipient 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunology, Pregnancy, Implantation Rate, Fertilization in Vitro, Oocyte donor egg recipient