Sep 29, 2023
Inclusion and Exclusion criteria
- pooja.devrukhkar 1,
- hannah.anvari 1,
- asma.giornazi Asma Giornazi1,
- shriya.shah 1,
- maryellen.pavone 1,
- francesca.e.duncan francesca.duncan1
- 1Northwestern Medicine OBGYN, Northwestern University
Protocol Citation: pooja.devrukhkar , hannah.anvari , asma.giornazi Asma Giornazi, shriya.shah , maryellen.pavone , francesca.e.duncan francesca.duncan 2023. Inclusion and Exclusion criteria . protocols.io https://dx.doi.org/10.17504/protocols.io.3byl4qzyjvo5/v1
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it's working
Created: September 29, 2023
Last Modified: September 29, 2023
Protocol Integer ID: 88565
Keywords: human follicular fluid, matched biofluid, exclusion criteria, exclusion criteria for collection, inclusion, ovarian tissue, purpose of this protocol, urine
Funders Acknowledgements:
SenNet
Grant ID: U54AG075932
Abstract
The purpose of this protocol is to describe the inclusion/exclusion criteria for collection of human follicular fluid, ovarian tissue, and matched biofluids (plasma and urine) for research.
Guidelines
Researchers will adhere to all safety and training protocols required by the institution including but not limited to:
1. Biosafety Certification
2. Bloodborne Pathogens Certification
3. Collaborative Institutional Training Initiative (CITI program) certification
Safety warnings
Researchers will wear personal protective equipment when working with human specimens, including gloves, masks, and lab coats.
Ethics statement
This protocol takes place under approved IRB protocol through Northwestern University (NU12G09) for collection of follicular fluid, human ovarian tissue, and biofluids through Northwestern Medicine.
Collection of Research Specimens for U54/UG3 – Done by Pathology
Human ovaries and follicular fluid are obtained following informed consent from the Northwestern University Reproductive Tissue Library (NU-RTL).
NU-RTL uses an established IRB-approved protocol that facilitates the acquisition of de-identified
human reproductive specimens including but not limited to gynecologic tissue (ovaries) and follicular fluid for research purposes.
Blood and urine can also be collected at the time of consent or procedure, and basic de-identified demographic and medical health information is also maintained.
Study-Specific Inclusion/Exclusion Criteria:
Inclusion Criteria
a. aged 18 and older (no upper age limit)
b. for ovarian tissue, women undergoing bilateral salpingo-oophorectomies (BSOs), with the absence of any ovarian neoplasia, as well as hysterectomies (along with Bilateral Salpingo- Oophorectomies) for conditions including but not limited to endometrial hyperplasia and prolapse where no ovarian neoplasia is identified.
c. for follicular fluid, women undergoing ART procedures for egg donation, male factor infertility, elective oocyte vitrification, and preimplantation genetic diagnosis for single gene disorders.
Exclusion Criteria
Women with endometriosis diagnosis