Microbiome and Polycystic Ovaries

NCT04836910 | Not Yet Recruiting

• 1 other identifier: 8032-20-SMC
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder among women in reproductive age with an estimated prevalence of 5% to 19.5%. It is a chronic complex syndrome with psychological (depression and anxiety), reproductive and metabolic abnormalities. The etiology seems to be multifactorial. Lately, interest regarding the association between PCOS women and gut macrobiotic have been emerged. Hyperandrogenism was correlated with those changes in the microbiota which reflects the fact that the microbiome can influence the development and pathology of PCOS . Therefore, aim of this study is to explore the diversity and alternations of the vaginal and the gut microbiome in patients with PCOS during common therapeutic interventions and connect them to different phenotypes of the syndrome.

Conditions

Polycystic Ovary Syndrome; Microbial Colonization

Keywords

polycystic ovaries, microbiome

Outcome Measures

Primary Outcomes (1)

• Vaginal and gut microbiota composition before and after intervention recommended and in comparison to women without PCOS.

  Evaluated by PCR ( ng/microl)

  Through study completion, an estimated period of 1 year

Secondary Outcomes (3)

• Hirsutism

  Through study completion, an estimated period of 1 year

• Acne

  Through study completion, an estimated period of 1 year

• Fertility

  Through study completion, an estimated period of 1 year

Study Arms (2)

Study Group: Women with Polycystic Ovary Syndrome

Woen diagnosed with Polycystic Ovary Syndrome according to the Rotterdam Criteria (requires 2 out of 3 symptoms: 1. Hyperandrogenism or excess levels of androgen. 2. Oligo or anovulation. 3. Polycystic ovaries on ultrasound - over 12 follicles, 2-9 mm or increased ovarian volume),who haven't started any treatment

Other: Dietary recommendations; Drug: Oral contraceptive pills; Drug: Metformin

Cohort Group: Women without Polycystic Ovary Syndrome

Interventions

Dietary recommendations OTHER

Fruit, vegetables, legumes (e.g. lentils and beans), nuts and whole grains (e.g. unprocessed maize, millet, oats, wheat and brown rice). At least 400 g (i.e. five portions) of fruit and vegetables per day excluding potatoes, sweet potatoes, cassava and other starchy roots. Less than 10% of total energy intake from free sugars Less than 30% of total energy intake from fats. Unsaturated fats (found in fish, avocado and nuts, and in sunflower, soybean, canola and olive oils) are preferable to saturated fats. Less than 5 g of salt (equivalent to about one teaspoon) per day.

Also known as: World Health Organisation (WHO) recommendations

Study Group: Women with Polycystic Ovary Syndrome

Oral contraceptive pills DRUG

Hormonal treatment

Study Group: Women with Polycystic Ovary Syndrome

Metformin DRUG

Insulin resistance treatment

Study Group: Women with Polycystic Ovary Syndrome

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study group will include 20 women in fertility age (age 18-42) diagnosed with PCOS according to the Rotterdam Criteria who haven't started any treatment. The control group would include healthy women matched by age.

You may qualify if:

• Study group: Untreated women diagnosed with PCOS that are planned for intervention.
• Control group: Women without PCOS visiting the gynecologic outpatient's clinics.

You may not qualify if:

• Endocrine abnormality ( Cushing's syndrome, congenital adrenal hyperplasia, thyroid disorder, hyperprolactinemia and androgen-secreting tumor).
• Premature ovarian failure 2. Active malignancy 3. Participants taking antibiotics/ probiotics, hormonal, vaginal or laxative medicine (in the previous week).
• \. Vaginitis/ Pelvic Inflammatory Disease (PID)

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Related Publications (8)

• American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Gynecology. ACOG Practice Bulletin No. 194: Polycystic Ovary Syndrome. Obstet Gynecol. 2018 Jun;131(6):e157-e171. doi: 10.1097/AOG.0000000000002656.

  PMID: 29794677 BACKGROUND

• Macut D, Bjekic-Macut J, Rahelic D, Doknic M. Insulin and the polycystic ovary syndrome. Diabetes Res Clin Pract. 2017 Aug;130:163-170. doi: 10.1016/j.diabres.2017.06.011. Epub 2017 Jun 12.

  PMID: 28646699 BACKGROUND

• Lizneva D, Suturina L, Walker W, Brakta S, Gavrilova-Jordan L, Azziz R. Criteria, prevalence, and phenotypes of polycystic ovary syndrome. Fertil Steril. 2016 Jul;106(1):6-15. doi: 10.1016/j.fertnstert.2016.05.003. Epub 2016 May 24.

  PMID: 27233760 BACKGROUND

• McCartney CR, Marshall JC. CLINICAL PRACTICE. Polycystic Ovary Syndrome. N Engl J Med. 2016 Jul 7;375(1):54-64. doi: 10.1056/NEJMcp1514916.

  PMID: 27406348 BACKGROUND

• Azziz R. Polycystic Ovary Syndrome. Obstet Gynecol. 2018 Aug;132(2):321-336. doi: 10.1097/AOG.0000000000002698.

  PMID: 29995717 BACKGROUND

• Azziz R, Carmina E, Chen Z, Dunaif A, Laven JS, Legro RS, Lizneva D, Natterson-Horowtiz B, Teede HJ, Yildiz BO. Polycystic ovary syndrome. Nat Rev Dis Primers. 2016 Aug 11;2:16057. doi: 10.1038/nrdp.2016.57.

  PMID: 27510637 BACKGROUND

• Lindheim L, Bashir M, Munzker J, Trummer C, Zachhuber V, Leber B, Horvath A, Pieber TR, Gorkiewicz G, Stadlbauer V, Obermayer-Pietsch B. Alterations in Gut Microbiome Composition and Barrier Function Are Associated with Reproductive and Metabolic Defects in Women with Polycystic Ovary Syndrome (PCOS): A Pilot Study. PLoS One. 2017 Jan 3;12(1):e0168390. doi: 10.1371/journal.pone.0168390. eCollection 2017.

  PMID: 28045919 BACKGROUND

• Hong X, Qin P, Huang K, Ding X, Ma J, Xuan Y, Zhu X, Peng D, Wang B. Association between polycystic ovary syndrome and the vaginal microbiome: A case-control study. Clin Endocrinol (Oxf). 2020 Jul;93(1):52-60. doi: 10.1111/cen.14198. Epub 2020 May 7.

  PMID: 32311120 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool samples for microbiome analysis, vaginal swab

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Communicable Diseases

Interventions

World Health Organization; Metformin

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; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

United Nations; International Agencies; Organizations; Health Care Economics and Organizations; Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Aya Mohr-Sasson, M.D

CONTACT

0523692906; mohraya@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 8, 2021
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

IL (1)