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

Polycystic Ovarian Syndrome Clinical Trial

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).

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01162447
• Other study ID #: MAR.YC.2008.0276
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 12, 2010
• Last updated: July 13, 2010
• Start date: February 2010
• Est. completion date: February 2011

Study information

• Verified date: February 2010
• Source: V.K.V. American Hospital, Istanbul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Locations

Country	Name	City	State
Turkey	American Hospital Women's Health Center	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
V.K.V. American Hospital, Istanbul

Country where clinical trial is conducted

Turkey,