Effect of Influenza Vaccination on Donor Egg Recipient Outcomes

NCT02946177 | Unknown Phase 4 FDA Drug

• 1 other identifier: 0627201601-DonorEgg
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Recurrent Miscarriage

Keywords

Immunology; Pregnancy; Implantation Rate; Fertilization in Vitro; Oocyte donor egg recipient

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy

  Intrauterine pregnancy with positive evidence of fetal heart beat

  8 weeks

Secondary Outcomes (2)

• Implantation Rate

  8 weeks

• Evidence of immune activation

  14 to 21 days (at time of egg retrieval)

Study Arms (2)

Influenza Vaccine

EXPERIMENTAL

O.5 mL single dose influenza vaccine suspension administered intramuscularly

Biological: Influenza Vaccine

Saline Injection

PLACEBO COMPARATOR

O.5 ml of sterile Saline administered intramuscularly

Other: Sterile Saline

Interventions

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.

Also known as: Seqirus afluria 2016-2017 formula

Influenza Vaccine

Sterile Saline OTHER

0.5 mL of sterile Saline administered im

Also known as: Saline

Saline Injection

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Center for Human Reproduction: lead
• Foundation for Human Reproduction: collaborator

Study Sites (1)

Center For Human Reproduction

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Infertility; Abortion, Habitual

Interventions

Influenza Vaccines; Sodium Chloride

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• David H Barad, MD, MS

  Director of Assisted Reproductive Technology

  PRINCIPAL INVESTIGATOR

• Norbert Gleicher, MD

  Medical Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 27, 2016
• Study Start: January 19, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)