Infertility, Recurrent Miscarriage
Conditions
Keywords
Immunology, Pregnancy, Implantation Rate, Fertilization in Vitro, Oocyte donor egg recipient
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 as donor egg recipients.
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.
Interventions
BIOLOGICALInfluenza 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.
OTHERSterile Saline
0.5 mL of sterile Saline administered im
Sponsors
Foundation for Human Reproduction
Center for Human Reproduction
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pregnancy | 8 weeks | Intrauterine pregnancy with positive evidence of fetal heart beat |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implantation Rate | 8 weeks | Number of clinical pregnancies per number of embryos transferred |
| 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 |
Countries
United States
Outcome results
None listed