Polycystic Ovary SyndromePCOSNCT03876665
The Experience of Living With Polycystic Ovary Syndrome in the Military
An observational study of Polycystic Ovary Syndrome, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to understand the experience of living with polycystic ovary syndrome (PCOS) as an active duty Service Woman. As part of a budding research program, this proposed study will lay the groundwork for future intervention studies targeting the management of PCOS in a military population. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2019to 30 Dec 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Active duty military women diagnosed with PCOS
Who may be able to join
- Women, active duty or prior (within 5 years) in the Army, Navy, Air Force or Marine Corps
- Diagnosed with PCOS
- 18 years of age or over
Who cannot join
- Reservist, Coast Guard, women who have separated or retired > 5 years ago
Trial locations and contacts
1 site in 1 country.
United States1 site
David Grant Medical Center
Travis Air Force Base, California, 94535
About this study
The purpose of this study is to understand the experience of living with polycystic ovary syndrome (PCOS) as an active duty Service Woman. As part of a budding research program, this proposed study will lay the groundwork for future intervention studies targeting the management of PCOS in a military population.
Read the detailed description
Using a qualitative descriptive approach with focus groups (FG) and individual interviews (II), the investigators will seek to describe the experience of living with PCOS as an active duty service woman (ADSW). This method will allow the investigators to obtain a comprehensive summary of living with PCOS in the every day terms of ADSW. The discussion in the (FG) meetings will be an effective way to supply information about what people think, or how they feel, or on the way they act. Advantages of this method include: (a) it can cover a large number of people in one session, (b) it is an efficient way of gaining a large amount of information in a short time, (c) it is comparatively easier to drive or conduct, and (d) it generates an opportunity to collect data from the group interaction, which concentrates on the topic of the researcher's interest [64, 65].
This proposed study will focus on six primary areas of inquiry: (a) experience of receiving PCOS diagnosis (b) symptoms experienced and methods of coping with them, (c) military-specific experience of managing and living with PCOS, (d) access to/availability of information related to PCOS and how they have applied it, (e) experience of support, and (f) present and future concerns about having PCOS.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- No intervention
- Keywords
- Polycystic Ovary Syndrome, Military, Service Women, Active Duty
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Focus Group | Active Duty Air Force, Army and Navy women diagnosed with PCOS.
Up to three focus groups per service branch will be conducted. Considering attrition for those who may volunteer and not show up for the FG session, the investigators will recruit up to 20 participants per site, with the goal of including a maximum of six participants per FG to maximize individual participation. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the PCOS experience of active duty service members
Information from focused groups (FG) discussions and individual interviews (II) will be transcribed, categorized and then organized into themes that describe the experiences of active duty service members
Measured: through study completion, up to 18 months
Describe the PCOS experience by branch of service
Information from focused groups (FG) discussions and individual interviews (II) will be transcribed, categorized and then organized into themes that describe the experiences by branch of service
Measured: through study completion, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start15 Aug 2019
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Grant U.S. Air Force Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Madigan Army Medical Center, United States Naval Medical Center, San Diego, Malcolm Grow Medical Clinics and Surgery Center
- Responsible party
- Sponsor
- Investigators
- Dawnkimberly Hopkins, PhD, Principal investigator, David Grant Medical CenterLeilani Siaki, PhD, Principal investigator, Madigan Army Medical CenterAbigail Yablonsky, PhD, Principal investigator, United States Naval Medical Center, San DiegoAngela Phillips, PhD, Principal investigator, Malcolm Grow Medical Clinics and Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876665
- Sponsor's protocol ID
- FWH#20200123H
- Acronym
- PCOS
- Status last verified
- Feb 2021
- First submitted
- 26 Feb 2019
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Azziz R, Carmina E, Dewailly D, Diamanti-Kandarakis E, Escobar-Morreale HF, Futterweit W, Janssen OE, Legro RS, Norman RJ, Taylor AE, Witchel SF; Task Force on the Phenotype of the Polycystic Ovary Syndrome of The Androgen Excess and PCOS Society. The Androgen Excess and PCOS Society criteria for the polycystic ovary syndrome: the complete task force report. Fertil Steril. 2009 Feb;91(2):456-88. doi: 10.1016/j.fertnstert.2008.06.035. Epub 2008 Oct 23.
PubMed 18950759Yildizhan B, Anik Ilhan G, Pekin T. The impact of insulin resistance on clinical, hormonal and metabolic parameters in lean women with polycystic ovary syndrome. J Obstet Gynaecol. 2016 Oct;36(7):893-896. doi: 10.3109/01443615.2016.1168376. Epub 2016 May 3.
PubMed 27140180Thessaloniki ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Consensus on infertility treatment related to polycystic ovary syndrome. Hum Reprod. 2008 Mar;23(3):462-77. doi: 10.1093/humrep/dem426.
PubMed 18308833Teede H, Deeks A, Moran L. Polycystic ovary syndrome: a complex condition with psychological, reproductive and metabolic manifestations that impacts on health across the lifespan. BMC Med. 2010 Jun 30;8:41. doi: 10.1186/1741-7015-8-41.
PubMed 20591140Hopkins D, Walker SC, Wilson C, Siaki L, Phillips AK, Wallen GR. The Experience of Living With Polycystic Ovary Syndrome in the Military. Mil Med. 2024 Jan 23;189(1-2):e188-e197. doi: 10.1093/milmed/usad241.
PubMed 37405691
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Experience of Living With Polycystic Ovary Syndrome in the Military
- ClinicalTrials.gov ID
- NCT03876665
- Acronym / sponsor ID
- PCOS / FWH#20200123H
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome, Military, Service Women, Active Duty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- David Grant U.S. Air Force Medical CenterUS federal agency
- Collaborators
- Madigan Army Medical Center, United States Naval Medical Center, San Diego, Malcolm Grow Medical Clinics and Surgery Center
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 15 Mar 2019 (actual)
- 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 purpose of this study is to understand the experience of living with polycystic ovary syndrome (PCOS) as an active duty Service Woman. As part of a budding research program, this proposed study will lay the groundwork for future intervention studies targeting the management of PCOS in a military population.
Detailed description
Using a qualitative descriptive approach with focus groups (FG) and individual interviews (II), the investigators will seek to describe the experience of living with PCOS as an active duty service woman (ADSW). This method will allow the investigators to obtain a comprehensive summary of living with PCOS in the every day terms of ADSW. The discussion in the (FG) meetings will be an effective way to supply information about what people think, or how they feel, or on the way they act. Advantages of this method include: (a) it can cover a large number of people in one session, (b) it is an efficient way of gaining a large amount of information in a short time, (c) it is comparatively easier to drive or conduct, and (d) it generates an opportunity to collect data from the group interaction, which concentrates on the topic of the researcher's interest [64, 65].
This proposed study will focus on six primary areas of inquiry: (a) experience of receiving PCOS diagnosis (b) symptoms experienced and methods of coping with them, (c) military-specific experience of managing and living with PCOS, (d) access to/availability of information related to PCOS and how they have applied it, (e) experience of support, and (f) present and future concerns about having PCOS.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focus Group | – | Other: No interventionActive Duty Air Force, Army and Navy women diagnosed with PCOS. Up to three focus groups per service branch will be conducted. Considering attrition for those who may volunteer and not show up for the FG session, the investigators will recruit up to 20 participants per site, with the goal of including a maximum of six participants per FG to maximize individual participation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Active duty military women diagnosed with PCOS
Key inclusion criteria (3 listed)
- Women, active duty or prior (within 5 years) in the Army, Navy, Air Force or Marine Corps
- Diagnosed with PCOS
- 18 years of age or over
Key exclusion criteria (1 listed)
- Reservist, Coast Guard, women who have separated or retired > 5 years ago
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 |
|---|---|---|
| No interventionNo intervention | Other | Focus Group |
Primary outcome
Describe the PCOS experience of active duty service members
Time frame: through study completion, up to 18 months
Information from focused groups (FG) discussions and individual interviews (II) will be transcribed, categorized and then organized into themes that describe the experiences of active duty service members
Describe the PCOS experience by branch of service
Time frame: through study completion, up to 18 months
Information from focused groups (FG) discussions and individual interviews (II) will be transcribed, categorized and then organized into themes that describe the experiences by branch of service
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 23 Feb 2021.
- Background: PubMed 18950759Azziz R, Carmina E, Dewailly D, Diamanti-Kandarakis E, Escobar-Morreale HF, Futterweit W, Janssen OE, Legro RS, Norman RJ, Taylor AE, Witchel SF; Task Force on the Phenotype of the Polycystic Ovary Syndrome of The Androgen Excess and PCOS Society. The Androgen Excess and PCOS Society criteria for the polycystic ovary syndrome: the complete task force report. Fertil Steril. 2009 Feb;91(2):456-88. doi: 10.1016/j.fertnstert.2008.06.035. Epub 2008 Oct 23.
- Background: PubMed 27140180Yildizhan B, Anik Ilhan G, Pekin T. The impact of insulin resistance on clinical, hormonal and metabolic parameters in lean women with polycystic ovary syndrome. J Obstet Gynaecol. 2016 Oct;36(7):893-896. doi: 10.3109/01443615.2016.1168376. Epub 2016 May 3.
- Background: PubMed 18308833Thessaloniki ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Consensus on infertility treatment related to polycystic ovary syndrome. Hum Reprod. 2008 Mar;23(3):462-77. doi: 10.1093/humrep/dem426.
- Background: PubMed 20591140Teede H, Deeks A, Moran L. Polycystic ovary syndrome: a complex condition with psychological, reproductive and metabolic manifestations that impacts on health across the lifespan. BMC Med. 2010 Jun 30;8:41. doi: 10.1186/1741-7015-8-41.
- Derived from this study: PubMed 37405691Hopkins D, Walker SC, Wilson C, Siaki L, Phillips AK, Wallen GR. The Experience of Living With Polycystic Ovary Syndrome in the Military. Mil Med. 2024 Jan 23;189(1-2):e188-e197. doi: 10.1093/milmed/usad241.
- Individual participant dataSharing planned: No
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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.
Dawnkimberly Hopkins, PhD principal investigator
David Grant Medical Center
Leilani Siaki, PhD principal investigator
Madigan Army Medical Center
Abigail Yablonsky, PhD principal investigator
United States Naval Medical Center, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by David Grant U.S. Air Force Medical Center 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 3 inclusion and 1 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 23 Feb 2021. 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. 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?
Describe the PCOS experience of active duty service members (time frame: through study completion, up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03876665, which also lists 5 linked publications.
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 23 Feb 2021.