Effect of Influenza Vaccination on Donor Egg Recipient Outcomes

Infertility Clinical Trial

— DE-FluVac  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02946177
• Other study ID #: 0627201601-DonorEgg
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: January 19, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2020
• Source: Center for Human Reproduction
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 126
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Infertility
• Recurrent Miscarriage

Intervention

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:
• Sterile Saline
0.5 mL of sterile Saline administered im

Locations

Country	Name	City	State
United States	Center For Human Reproduction	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Center for Human Reproduction	Foundation for Human Reproduction

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Pregnancy	Intrauterine pregnancy with positive evidence of fetal heart beat	8 weeks
Secondary	Implantation Rate	Number of clinical pregnancies per number of embryos transferred	8 weeks
Secondary	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)