NCT02087410

Brief Summary

measuring serum gherlin in polycystic ovary syndrome patients and compare it to healthy levels

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 14, 2014

Status Verified

March 1, 2014

Enrollment Period

6 months

First QC Date

March 12, 2014

Last Update Submit

March 13, 2014

Conditions

Polycystic Ovary

Outcome Measures

Primary Outcomes (1)

  • relationships between circulating ghrelin and the clinical and biochemical manifestations of PCOS

    Analysis of levels of ghrelin in study group

    after 6 monthes

Study Arms (2)

study

patients with polycystic ovary syndrome

control

healthy patients serves as control group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Forty two patients with polycystic ovarian syndrome and forty two healthy subjects will be recruited from the outpatient clinic Ain Shams University Maternity Hospital.

You may qualify if:

  • At least 12 months of infertility.
  • Patients with polycystic ovarian syndrome according to Rotterdam criteria:

You may not qualify if:

  • Patients with hyperprolactinemia
  • Patients with Cushing's syndrome
  • Patients with Congenital or non-classical adrenal hyperplasia
  • Patients with hormone secreting tumors.
  • Patients with hormonal treatment in the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternity Hospital

Cairo, Cairo Governorate, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • amr eletrby, MBBCH

    ain shams universty maternity hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
resident maternity hospital

Study Record Dates

First Submitted

March 12, 2014

First Posted

March 14, 2014

Study Start

April 1, 2014

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

March 14, 2014

Record last verified: 2014-03

Locations

EG(1)