The Experience of Living With Polycystic Ovary Syndrome in the Military

NCT03876665 | Completed

• 1 other identifier: FWH#20200123H
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome; Military; Service Women; Active Duty

Outcome Measures

Primary Outcomes (2)

• 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

  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

  through study completion, up to 18 months

Study Arms (1)

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.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Focus Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female specific condition
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Active duty military women diagnosed with PCOS

You may qualify if:

• Women, active duty or prior (within 5 years) in the Army, Navy, Air Force or Marine Corps
• Diagnosed with PCOS
• years of age or over

You may not qualify if:

• Reservist, Coast Guard, women who have separated or retired \> 5 years ago

Sponsors & Collaborators

• David Grant U.S. Air Force Medical Center: lead
• Madigan Army Medical Center: collaborator
• United States Naval Medical Center, San Diego: collaborator
• Malcolm Grow Medical Clinics and Surgery Center: collaborator

Study Sites (1)

David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

Related Publications (4)

• 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.

  PMID: 18950759 BACKGROUND

• Yildizhan 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.

  PMID: 27140180 BACKGROUND

• Thessaloniki 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.

  PMID: 18308833 BACKGROUND

• Teede 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.

  PMID: 20591140 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Dawnkimberly Hopkins, PhD

  David Grant Medical Center

  PRINCIPAL INVESTIGATOR

• Leilani Siaki, PhD

  Madigan Army Medical Center

  PRINCIPAL INVESTIGATOR

• Abigail Yablonsky, PhD

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

• Angela Phillips, PhD

  Malcolm Grow Medical Clinics and Surgery Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 15, 2019
• Study Start: August 15, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)