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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
V.K.V. American Hospital, Istanbul
ClinicalTrials.gov Identifier:
NCT01162447
First received: July 12, 2010
Last updated: July 13, 2010
Last verified: February 2010
  Purpose

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
Polycystic Ovarian Syndrome

Study Type: Observational
Study Design: 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).

Resource links provided by NLM:


Further study details as provided by V.K.V. American Hospital, Istanbul:

Biospecimen Retention:   Samples With DNA

Blood samples, ovarian tissue samples, ovarian follicular fluid samples


Estimated Enrollment: 50
Study Start Date: February 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
PCO
Healthy control subjects and patients with polycystic ovarian syndrome will be recruited for the study.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders 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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162447

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

No publications provided

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
Study First Received: July 12, 2010
Last Updated: July 13, 2010
Health Authority: Turkey: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 19, 2014