ClinicalTrials.gg
Status unknownNCT02467751PCOSUpdated Mar 20, 2017

Women With Polycystic Ovary Syndrome (PCOS)

An observational study in Polycystic Ovary Syndrome, sponsored by Irmandade da Santa Casa de Misericordia de Sao Paulo. Status unknown at 1 site in Brazil. Open to female participants aged 12 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-20.

Sponsored by Irmandade da Santa Casa de Misericordia de Sao Paulo · Observational

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
90
Ages
12 Years to 39 Years
Sex
Female
01

Study summary

Metabolic profile in women of different body composition with polycystic ovary syndrome.

Read the detailed description

Will be performed case-control study with women with Polycystic Ovary Syndrome, according to the Rotterdam criteria and body mass index between 18 to 29.9. The control group will consist of women without Polycystic Ovary Syndrome, with a body mass index of 18 to 29.9 and no other comorbidities. In both groups collect anthropometric data such as age, weight, height, waist circumference and blood pressure. Exams will be requested: metabolic profile (total cholesterol (mg/dL) and fractions, triglycerides (mg/dL), blood count, liver function (U/L) and classical glycemic index (mg/dL); hormonal profile - insulin (uIU/ml), luteinizing hormone (IU/L), follicle stimulating hormone (IU/L), thyreostimulating hormone (uIU/ML), total and free testosterone (ng/ml), 17-hydroxyprogesterone (ng/ml), dehydroepiandrosterone (ng/ml), prolactin (ug/ml). Body composition (BMI) will be performed by absorption technique of two low energy beams emitted by X-ray - full body densitometry (DEXA). Expected result: To evaluate visceral fat and truncal of patients with diagnosis of Polycystic Ovary Syndrome without obesity.

02

Conditions studied

  • Polycystic Ovary Syndrome
03

In context

Polycystic Ovary Syndrome

975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.

This study's planned enrollment of 90 is below the median of 106 across 229 observational studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Irmandade da Santa Casa de Misericordia de Sao Paulo is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Will be performed case-control study with women with Polycystic Ovary Syndrome, according to the Rotterdam criteria and body mass index between 18 to 29.9. The control group will consist of women without Polycystic Ovary Syndrome, with a body mass index of 18 to 29.9 and no other comorbidities.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Polycystic Ovary Syndrome , body mass index of 18 to 29.9, without contraceptive use.

Exclusion criteria

Exclusion Criteria:

  • Hypothyroidism, hyperprolactinaemia (defined as serum prolactin levels greater than 25 ng/mL)
  • Cushing's syndrome
  • Nonclassical congenital adrenal hyperplasia (defined as serum 17-hydroxyprogesterone levels greater than 1.2 and 5.2 ng/mL in the follicular and luteal phase, respectively) and current or previous (within the last three months) use of oral contraceptives and other hormonal
  • Antidiabetic and antiobesity drugs.
05

Study design

Observational model
Case-crossover
Time perspective
Cross-sectional
Enrollment
90 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Metabolic profile

    total cholesterol (mg/dL) and fractions, triglycerides (mg/dL) will estimate

    Time frame: 12 months

Secondary outcomes

  1. Classical glycemic index

    Classical glycemic index (mg/dL) will estimate

    Time frame: 12 months

  2. Liver function

    Liver function (U/L) will estimate

    Time frame: 12 months

  3. luteinizing hormone

    luteinizing hormone (IU/L) will estimate

    Time frame: 12 months

  4. Hormonal profile - insulin

    Hormonal profile - insulin (uIU/ml) will estimate

    Time frame: 12 months

  5. Follicle stimulating hormone

    Follicle stimulating hormone (IU/L) will estimate

    Time frame: 12 months

  6. thyreostimulating hormone

    thyreostimulating hormone (uIU/ML) will estimate

    Time frame: 12 months

  7. Total and free testosterone

    Total and free testosterone (ng/ml) will estimate

    Time frame: 12 months

  8. 17-hydroxyprogesterone

    17-hydroxyprogesterone (ng/ml) will estimate

    Time frame: 12 months

  9. Dehydroepiandrosterone

    Dehydroepiandrosterone (ng/ml) will estimate

    Time frame: 12 months

  10. Prolactin

    Prolactin (ug/ml) will estimate

    Time frame: 12 months

  11. DEXA

    Body composition will measure by DEXA scan

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Carolina Furtado Macruz
    São Paulo, São Paulo 01225001, Brazil
    Recruiting
08

References and documents

Publications

  • Macruz CF, Lima SMRR. Polycystic ovary syndrome and abdominal fat: is there a relationship? Rev Assoc Med Bras (1992). 2023 Oct 27;69(11):e20230874. doi: 10.1590/1806-9282.20230874. eCollection 2023. PubMed 37909624 ↗
  • Macruz CF, Lima SM, Salles JE, da Silva GM, Scalissi NM. Assessment of the body composition of patients with polycystic ovary syndrome using dual-energy X-ray absorptiometry. Int J Gynaecol Obstet. 2017 Mar;136(3):285-289. doi: 10.1002/ijgo.12066. Epub 2017 Jan 6. PubMed 28099715 ↗

Individual participant data

Plan to share: No — When I have finished my recruitment and analysis of the results.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2014, a primary completion of Sep 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 25, 2015
First posted
Jun 10, 2015
Start
Jan 2014
Primary completionEst.
Sep 2017
CompletionEst.
Dec 2017
Last update
Mar 20, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02467751
Lead sponsor
Irmandade da Santa Casa de Misericordia de Sao Paulo
Responsible party
Carolina Furtado Macruz (Doctor, Irmandade da Santa Casa de Misericordia de Sao Paulo) — Principal investigator
First posted
Jun 10, 2015
Start date
Jan 2014
Primary completion
Sep 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Mar 20, 2017

Study contacts

Carolina F Macruz, doctor
Contact
carolmacruz@gmail.com
+5511999141447 ext. Brazil
Irmandade Santa Casa Sao Paulo
Contact
+551121767385 ext. Brazil
Carolina Macruz
principal investigator · Irmandade Santa Casa de Misericordia Sao Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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