Interferon Expression in the Female Reproductive TractEpsilonNCT02416154
Expression of IFN-epsilon in the Female Reproductive Tract
An observational study of Interferon Expression in the Female Reproductive Tract, run by University of Pittsburgh at 2 sites in United States.
Trial summary
The proposed study aims to determine the expression of Interferon-ε (IFNε) in the female genital tract, which has never been mapped before in humans. High expression in other mammalian female reproductive tract (FRT) has been suggested to be important in anti-sexually transmitted infection (STI)/HIV immunity and its… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Interferon Expression in the Female Reproductive Tract
- What is being tested?
- Reproductive tract and blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to May 2020
- Phase
- Observational
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy females aged18 through 35 years (inclusive) at screening
Who may be able to join
- Age 18 through 35 years (inclusive) at screening
- Non-pregnant women in general good health as determined by the site clinician
- Premenopausal with history of regular menstrual cycles (regular cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days)
- Regular and consistent condom use, prior surgical sterilization by participant or sexual partner, or heterosexually abstinent since last menses prior to enrollment
- Able and willing to provide written informed consent to be screened for and to take part in the study, including willingness to undergo all study-related assessments and follow all study-related procedures
- Able and willing to provide adequate locator information
- HIV-uninfected based on testing performed by study staff at enrollment
Who cannot join
- Use of any hormonal or intrauterine contraceptive method within 30 days of enrollment
- Use of depot medroxyprogesterone acetate (DMPA) within 10 months of enrollment
- Pregnancy or breastfeeding within 60 days of enrollment
- Surgical procedure involving the pelvis in the 30 days prior to enrollment (includes dilation and curettage, cryosurgery and biopsy of the vagina, vulva, cervix, and endometrium)
- Internal vaginal use of any device (includes sex toys, cervical caps, diaphragms, menstrual collection devices, and pessaries; excludes tampons and condoms) or product (includes spermicide, microbicide, douche, antifungal, steroid, or hormone) in the 30 days prior to enrolment (includes investigational products and devices)
- New sexual partner within 90 days of enrollment
Show all 15Show fewer
- Urogenital infection or suspected infection within 30 days of enrollment including: symptomatic candidiasis, trichomonas vaginalis, and symptomatic bacterial vaginosis; or cervical infection, including N. gonorrhoea (GC), C. trachomatis (CT), or mucopurulent cervicitis; syphilis; herpes simplex virus (HSV) lesions, or other sores (Note: seropositive HSV without active lesions will not be excluded); acute pelvic inflammatory disease; urinary tract infection; recent exposure to a partner with GC, CT, Trichomonas, syphilis, or non-gonococcal urethritis (NGU)
- Any history of immunosuppression (includes diabetes, HIV infection, and chronic steroid use or other immunosuppressive medications)
- Antibiotic or antifungal therapy (vaginal or systemic) within 30 days of enrollment
- Menses or other vaginal bleeding at the time of enrollment* (*Women who have vaginal bleeding at the scheduled enrollment visit may return at a different date to be re-examined and possibly enrolled provided they are still within the 90-day screening window and meet all criteria).
- Vaginal or anal intercourse within 36 hours prior to enrollment
- Heterosexual intercourse since last menses that places the participant at risk of pregnancy (without condom use or sterilization of at least one partner)
- History of hysterectomy
- History of malignancy within the pelvis (includes uterus, cervix, vagina, and vulva)
- Any condition that, in the opinion of the Investigator, would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Family Planning Research
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: IFN-epsilon and Hormonal Contraceptive Modulation of the Risk of HIV Acquisition, Part 1: Expression in the Female Reproductive Tract
The proposed study aims to determine the expression of Interferon-ε (IFNε) in the female genital tract, which has never been mapped before in humans. High expression in other mammalian female reproductive tract (FRT) has been suggested to be important in anti-sexually transmitted infection (STI)/HIV immunity and its expression decreases with progestogen treatment. Future studies are planned to understand if hormonal contraceptives affect the presence of interferon in the healthy female genital tract, potentially changing the risk of for STI and HIV.
Read the detailed description
Objectives:
- To optimize measurement protocols for IFNε and related biomarkers in samples from the female reproductive tract.
- To quantify and characterize IFNε expression in the upper and lower genital tract and blood in normally cycling women during the follicular and luteal phases of the menstrual cycle.
Study design: This is a single site, parallel cross-sectional study
Specific Aims:
The aim of this study is to determine which "IFNε -related assays" can be performed on different types of FRT samples. The possible "IFNε-related assays" are:
- IFNε messenger ribonucleic acid (mRNA) levels by quantitative reverse transcriptase polymerase chain reaction (qRT PCR) (requiring frozen tissue processed for RNA)
- IFN Regulated Gene expression by qRT PCR, microarray or targeted gene set using Fluidigm platform (frozen tissue)
- PR and ER gene expression (as above)
- IFNε tissue protein levels* (by immunoassay) and progesterone and estrogen receptors (PR/ER) by Western blotting (frozen tissue)
- IFNε and Neopterin (a well characterized compound whose production can be stimulated by IFNs and whose specificity in this setting needs validation) or other IFNε-biomarkers** by immunoassay in cervicovaginal lavage (CVL) fluids
- Immunohistochemistry of IFNε, PR/ER, + other (e.g. cells, cytokines) (fixed tissue)
- Studies of FRT samples from wild type and IFNε-/- mice would be used to first validate Neopterin as a "biomarker" of IFNε activity in the FRT; and microarray analyses may reveal other secreted proteins that may be used as "biomarkers" of IFNε activity.
- Being tested
- Reproductive tract and blood sampling
- Keywords
- interferon-epsilon, female reproductive tract, neopterin, menstrual cycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reproductive tract and blood samplingProcedure or surgery
Reproductive tract and blood sampling will be performed at enrollment only in this cross-sectional parallel cohort study.
| Study group | Role | What they receive |
|---|---|---|
| Follicular phase | Normally cycling women in the follicular phase of menses Receives: Procedure: Reproductive tract and blood sampling | |
| Luteal phase | Normally cycling women in the luteal phase of menses Receives: Procedure: Reproductive tract and blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interferon epsilon expression
Interferon epsilon expression will be assessed in the female reproductive tract and blood in women in the follicular phase of menses vs the luteal phase of menses in this cross-sectional study.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interferon Expression in the Female Reproductive TractStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, MIMR-PHI Institute, Australia
- Responsible party
- Principal investigator, Sharon Achilles, University of Pittsburgh
- Investigators
- Paul Hertzog, PhD, Principal investigator, Hudson Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416154
- Sponsor's protocol ID
- OPP1108501
- Acronym
- Epsilon
- Status last verified
- Dec 2021
- First submitted
- 9 Apr 2015
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IFN-epsilon and Hormonal Contraceptive Modulation of the Risk of HIV Acquisition, Part 1: Expression in the Female Reproductive Tract
- ClinicalTrials.gov ID
- NCT02416154
- Acronym / sponsor ID
- Epsilon / OPP1108501
- Keywords
- interferon-epsilon, female reproductive tract, neopterin, menstrual cycle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, MIMR-PHI Institute, Australia
- Study start
- Jul 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 14 Apr 2015 (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.
The proposed study aims to determine the expression of Interferon-ε (IFNε) in the female genital tract, which has never been mapped before in humans. High expression in other mammalian female reproductive tract (FRT) has been suggested to be important in anti-sexually transmitted infection (STI)/HIV immunity and its expression decreases with progestogen treatment. Future studies are planned to understand if hormonal contraceptives affect the presence of interferon in the healthy female genital tract, potentially changing the risk of for STI and HIV.
Detailed description
Objectives:
- To optimize measurement protocols for IFNε and related biomarkers in samples from the female reproductive tract.
- To quantify and characterize IFNε expression in the upper and lower genital tract and blood in normally cycling women during the follicular and luteal phases of the menstrual cycle.
Study design: This is a single site, parallel cross-sectional study
Specific Aims:
The aim of this study is to determine which "IFNε -related assays" can be performed on different types of FRT samples. The possible "IFNε-related assays" are:
- IFNε messenger ribonucleic acid (mRNA) levels by quantitative reverse transcriptase polymerase chain reaction (qRT PCR) (requiring frozen tissue processed for RNA)
- IFN Regulated Gene expression by qRT PCR, microarray or targeted gene set using Fluidigm platform (frozen tissue)
- PR and ER gene expression (as above)
- IFNε tissue protein levels* (by immunoassay) and progesterone and estrogen receptors (PR/ER) by Western blotting (frozen tissue)
- IFNε and Neopterin (a well characterized compound whose production can be stimulated by IFNs and whose specificity in this setting needs validation) or other IFNε-biomarkers** by immunoassay in cervicovaginal lavage (CVL) fluids
- Immunohistochemistry of IFNε, PR/ER, + other (e.g. cells, cytokines) (fixed tissue)
- Studies of FRT samples from wild type and IFNε-/- mice would be used to first validate Neopterin as a "biomarker" of IFNε activity in the FRT; and microarray analyses may reveal other secreted proteins that may be used as "biomarkers" of IFNε activity.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follicular phase | – | Procedure: Reproductive tract and blood samplingNormally cycling women in the follicular phase of menses |
| Luteal phase | – | Procedure: Reproductive tract and blood samplingNormally cycling women in the luteal phase of menses |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy females aged18 through 35 years (inclusive) at screening
Key inclusion criteria (7 listed)
- Age 18 through 35 years (inclusive) at screening
- Non-pregnant women in general good health as determined by the site clinician
- Premenopausal with history of regular menstrual cycles (regular cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days)
- Regular and consistent condom use, prior surgical sterilization by participant or sexual partner, or heterosexually abstinent since last menses prior to enrollment
- Able and willing to provide written informed consent to be screened for and to take part in the study, including willingness to undergo all study-related assessments and follow all study-related procedures
Key exclusion criteria (15 listed)
- Use of any hormonal or intrauterine contraceptive method within 30 days of enrollment
- Use of depot medroxyprogesterone acetate (DMPA) within 10 months of enrollment
- Pregnancy or breastfeeding within 60 days of enrollment
- Surgical procedure involving the pelvis in the 30 days prior to enrollment (includes dilation and curettage, cryosurgery and biopsy of the vagina, vulva, cervix, and endometrium)
- Internal vaginal use of any device (includes sex toys, cervical caps, diaphragms, menstrual collection devices, and pessaries; excludes tampons and condoms) or product (includes spermicide, microbicide, douche, antifungal, steroid, or hormone) in the 30 days prior to enrolment (includes investigational products and devices)
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 |
|---|---|---|
| Reproductive tract and blood samplingReproductive tract and blood sampling will be performed at enrollment only in this cross-sectional parallel cohort study. | Procedure or surgery | Follicular phase, Luteal phase |
Primary outcome
Interferon epsilon expression
Time frame: baseline
Interferon epsilon expression will be assessed in the female reproductive tract and blood in women in the follicular phase of menses vs the luteal phase of menses in this cross-sectional study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
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.
Paul Hertzog, PhD principal investigator
Hudson Institute of Medical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interferon Expression in the Female Reproductive Tract, run by University of Pittsburgh at 2 sites 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 7 inclusion and 15 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: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Interferon epsilon expression (time frame: baseline). 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 27 Dec 2021.