The Experience of Living With Polycystic Ovary Syndrome in the Military

Polycystic Ovary Syndrome Clinical Trial

— PCOS  

Official title:

The Experience of Living With Polycystic Ovary Syndrome in the Military

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03876665
• Other study ID #: FWH#20200123H
• Status: Completed
• Start date: August 15, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2021
• Source: David Grant U.S. Air Force Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
United States	David Grant Medical Center	Travis Air Force Base	California

Sponsors (4)

Lead Sponsor	Collaborator
David Grant U.S. Air Force Medical Center	Madigan Army Medical Center, Malcolm Grow Medical Clinics and Surgery Center, United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

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. Review. — View Citation

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. Erratum in: Hum Reprod. 2008 Jun;23(6):1474. — View Citation

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. Epub 2016 May 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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