Comparison of Bone Morphogenetic Protein-4 (BMP-4) and 7 Levels Between Control and Polycystic Ovarian Syndrome (PCOS) Patients.

NCT ID: NCT01162447

Last Updated: 2010-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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Female patients at ages 20-35 diagnosed with polycystic ovarian syndrome and age-matched healthy control subjects will be enrolled in this study.

Blood samples will be obtained at early follicular phase during doctor's visit from PCOS patients and control subjects.If the patient is amenorrheic at the time of visit, both random blood samples and another sample at early follicular phase after induction of withdrawal bleeding with progesterone.

Follicular fluids will be retrieved during oocyte pick-up procedure in patients undergoing assisted reproduction for PCOS and control IVF patients whose infertility is not PCO related.

Samples from ovaries will be collected at operation from PCOS patients and control subjects if they already undergo any gynecologic laparotomi operations.

Collected samples will be cultured for 7 days and BMP-4 and -7 levels will be measured in the culture fluid of the samples using ELISA method.

Conditions

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Polycystic Ovarian Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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PCO

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Those with any metabolic or endocrine problems other than PCOS will be excluded from the study.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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V.K.V. American Hospital, Istanbul

OTHER

Sponsor Role lead

Responsible Party

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V.K.V. American Hospital Women's health center

Principal Investigators

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Bulent Urman, MD

Role: STUDY_DIRECTOR

VKV American Hospital Women's Health center

Locations

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American Hospital Women's Health Center

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MAR.YC.2008.0276

Identifier Type: -

Identifier Source: org_study_id

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