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| Name | Class |
|---|---|
| Foundation for Human Reproduction | UNKNOWN |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza Vaccine | Experimental | O.5 mL single dose influenza vaccine suspension administered intramuscularly |
|
| Saline Injection | Placebo Comparator | O.5 ml of sterile Saline administered intramuscularly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Pregnancy | Intrauterine pregnancy with positive evidence of fetal heart beat | 8 weeks |
| 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 |
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Inclusion Criteria:
All women preparing to undergo an oocyte donor recipient cycle
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David H Barad, MD, MS | Director of Assisted Reproductive Technology | Principal Investigator |
| Norbert Gleicher, MD | Medical Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center For Human Reproduction | New York | New York | 10021 | United States |
We do not plan to share individual participant data (IPD)
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D000026 | Abortion, Habitual |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| Sterile Saline | Other | 0.5 mL of sterile Saline administered im |
|
|
| 14 to 21 days (at time of egg retrieval) |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |