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

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ClinicalTrials.gov Identifier: NCT01162447
Recruitment Status : Unknown
Verified February 2010 by V.K.V. American Hospital, Istanbul.
Recruitment status was:  Enrolling by invitation
First Posted : July 14, 2010
Last Update Posted : July 14, 2010
Information provided by:
V.K.V. American Hospital, Istanbul

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.

Condition or disease
Polycystic Ovarian Syndrome

Detailed Description:

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.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Comparison of Bone Morphogenetic Protein-4 and -7 Levels (BMP-4 and 7) in the Serum, Ovarian Follicle Aspirates and Ovarian Organ Culture Supernatants Between Healthy Controls and Patients With Polycystic Ovarian Syndrome (PCOS).
Study Start Date : February 2010
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Biospecimen Retention:   Samples With DNA
Blood samples, ovarian tissue samples, ovarian follicular fluid samples

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162447

American Hospital Women's Health Center
Istanbul, Turkey, 34365
Sponsors and Collaborators
V.K.V. American Hospital, Istanbul
Study Director: Bulent Urman, MD VKV American Hospital Women's Health center

Responsible Party: Ozgur Oktem, V.K.V. American Hospital Women's health center
ClinicalTrials.gov Identifier: NCT01162447     History of Changes
Other Study ID Numbers: MAR.YC.2008.0276
First Posted: July 14, 2010    Key Record Dates
Last Update Posted: July 14, 2010
Last Verified: February 2010

Keywords provided by V.K.V. American Hospital, Istanbul:
BMP- 4 and 7, polycystic ovarian syndrome

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases