Comparison of Bone Morphogenetic Protein-4 (BMP-4) and 7 Levels Between Control and Polycystic Ovarian Syndrome (PCOS) Patients.
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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). |
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 |
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.
Contacts and Locations| Turkey | |
| American Hospital Women's Health Center | |
| Istanbul, Turkey, 34365 | |
| 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 Ovarian Cysts Cysts Neoplasms Ovarian Diseases |
Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013