InfertilityPhase 4DE-FluVacNCT02946177
Effect of Influenza Vaccination on Donor Egg Recipient Outcomes
A Phase 4 study testing Influenza Vaccine and Sterile Saline in people with Infertility and Recurrent Miscarriage, run by Center for Human Reproduction at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Recurrent Miscarriage
- What is being tested?
- Influenza Vaccine and Sterile Saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2017to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center For Human Reproduction
New York, New York, 10021
About this study
Official title: A Randomized Controlled Trial of the Effect of Influenza Vaccination on Implantation and Pregnancy Rates After Donor Egg Recipient In-Vitro Fertilization
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.
Read the 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:
- 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.
- Conditions
- Infertility, Recurrent Miscarriage
- Being tested
- Influenza Vaccine, Sterile Saline
- Keywords
- Immunology, Pregnancy, Implantation Rate, Fertilization in Vitro, Oocyte donor egg recipient
- Medical subject headings
- Infertility, Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza VaccineBiological
Also called Seqirus afluria 2016-2017 formula
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.
Sterile SalineOther
Also called Saline
0.5 mL of sterile Saline administered im
| Study group | Role | What they receive |
|---|---|---|
| Influenza Vaccine | Experimental | O.5 mL single dose influenza vaccine suspension administered intramuscularly Receives: Biological: Influenza Vaccine |
| Saline Injection | Placebo comparator | O.5 ml of sterile Saline administered intramuscularly Receives: Other: Sterile Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy
Intrauterine pregnancy with positive evidence of fetal heart beat
Measured: 8 weeks
Secondary outcomes (2)
Implantation Rate
Number of clinical pregnancies per number of embryos transferred
Measured: 8 weeks
Evidence of immune activation
Evidence of peripheral markers of immune pathways activated by the influenza vaccine
Measured: 14 to 21 days (at time of egg retrieval)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start19 Jan 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Human Reproduction
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Human Reproduction
- Responsible party
- Sponsor
- Investigators
- David H Barad, MD, MS, Principal investigator, Director of Assisted Reproductive TechnologyNorbert Gleicher, MD, Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946177
- Sponsor's protocol ID
- 0627201601-DonorEgg
- Acronym
- DE-FluVac
- Status last verified
- Feb 2020
- First submitted
- 25 Oct 2016
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual participant data (IPD)
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effect of Influenza Vaccination on Implantation and Pregnancy Rates After Donor Egg Recipient In-Vitro Fertilization
- ClinicalTrials.gov ID
- NCT02946177
- Acronym / sponsor ID
- DE-FluVac / 0627201601-DonorEgg
- Conditions
- Infertility, Recurrent Miscarriage
- Keywords
- Immunology, Pregnancy, Implantation Rate, Fertilization in Vitro, Oocyte donor egg recipient
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Center for Human ReproductionUniversity, hospital or other
- Collaborators
- Foundation for Human Reproduction
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza Vaccine | Experimental | Biological: Influenza VaccineO.5 mL single dose influenza vaccine suspension administered intramuscularly |
| Saline Injection | Placebo comparator | Other: Sterile SalineO.5 ml of sterile Saline administered intramuscularly |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All women preparing to undergo an oocyte donor recipient cycle
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza VaccineAlso: Seqirus afluria 2016-2017 formulaInactivated 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. | Biological | Influenza Vaccine |
| Sterile SalineAlso: Saline0.5 mL of sterile Saline administered im | Other | Saline Injection |
Primary outcome
Clinical Pregnancy
Time frame: 8 weeks
Intrauterine pregnancy with positive evidence of fetal heart beat
2 secondary outcomes
Implantation Rate
Time frame: 8 weeks
Evidence of immune activation
Time frame: 14 to 21 days (at time of egg retrieval)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data (IPD)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David H Barad, MD, MS principal investigator
Director of Assisted Reproductive Technology
Norbert Gleicher, MD study director
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Influenza Vaccine and Sterile Saline in people with Infertility and Recurrent Miscarriage, run by Center for Human Reproduction at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.