IVF-FluVac: Effect of Influenza Vaccination on IVF Outcomes - IVF

• Sponsor: Center for Human Reproduction (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT02947217
• Collaborator: Foundation for Human Reproduction (Other)
• Enrollment: 238
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 95.4
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Biological: Influenza Vaccine; Other: Sterile Saline	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 238 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of the Effect of Influenza Vaccination on Implantation and Pregnancy Rates After In-Vitro Fertilization
• Actual Study Start Date: Jan 19, 2017
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Clinical Pregnancy [8 weeks]

   Intrauterine pregnancy with positive evidence of fetal heart beat

Secondary Outcome Measures

1. Implantation Rate [8 weeks]

   Number of clinical pregnancies per number of embryos transferred

2. Evidence of immune activation [14 to 21 days (at time of egg retrieval)]

   Evidence of peripheral markers of immune pathways activated by the influenza vaccine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 38 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center For Human Reproduction	New York	New York	United States	10021

Sponsors and Collaborators

• Center for Human Reproduction
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Center for Human Reproduction
• ClinicalTrials.gov Identifier: NCT02947217
• Other Study ID Numbers: 06272016-01 - IVF
• First Posted: Oct 27, 2016
• Last Update Posted: Mar 10, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Center for Human Reproduction: Immunology; Pregnancy; Implantation Rate; Fertilization in Vitro
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Mar 10, 2022