NCT01162447

Brief Summary

The investigators aim to compare the levels of bone morphogenetic protein-4 and -7 (BMP-4 and 7) in blood, follicular fluid and ovarian organ culture supernatant obtained from healthy subjects and polycystic ovarian syndrome (PCOS) patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

July 14, 2010

Status Verified

February 1, 2010

Enrollment Period

1 year

First QC Date

July 12, 2010

Last Update Submit

July 13, 2010

Conditions

Polycystic Ovarian Syndrome

Keywords

BMP- 4 and 7, polycystic ovarian syndrome

Study Arms (1)

PCO

Healthy control subjects and patients with polycystic ovarian syndrome will be recruited for the study.

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who present to the women's health center of American Hospoital for complaints due to polcystic ovarian syndrome will be enrolled. Age-matched healthy subjects will be chosen for comparison.

You may qualify if:

  • Healthy subjects and PCOS patients at ages 20-35 will be recruited for the study.

You may not qualify if:

  • Those with any metabolic or endocrine problems other than PCOS will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American Hospital Women's Health Center

Istanbul, 34365, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, ovarian tissue samples, ovarian follicular fluid samples

MeSH Terms

Conditions

Polycystic Ovary SyndromeMicrophthalmia, Syndromic 6

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Bulent Urman, MD

    VKV American Hospital Women's Health center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 12, 2010

First Posted

July 14, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

July 14, 2010

Record last verified: 2010-02

Locations

TU(1)