NCT02869750

Brief Summary

To evaluate possible clinical effects of adipokines , ( ghrelin, resistin and adiponectin), in obese and non-obese patients with polycystic ovary syndrome (PCOS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

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

August 5, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

October 2, 2018

Status Verified

February 1, 2018

Enrollment Period

1.8 years

First QC Date

August 5, 2016

Last Update Submit

September 30, 2018

Conditions

Polycystic Ovarian Syndrome

Outcome Measures

Primary Outcomes (3)

  • serum ghrelin level

    measuring ghrelin, and ) in the three groups

    24 hours

  • serum resistin level

    serum resistin level in the three groups

    24 hours

  • serum adiponectin level

    serum adiponectin level in the three groups

    24 hours

Secondary Outcomes (2)

  • Glucose/Insulin ratio

    24 hours

  • serum testosterone level

    24 hours after labor

Study Arms (4)

Obese PCOS

PCOS patients with BMI more than 25 kg/m2

Lean PCOS

PCOS patients with BMI less than 25 kg/m2

PCOS with normal HOMA2-1R

PCOS without Insuline resistance

PCOS with elevated HOMA2-IR

PCOS with Insuline resistance

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Females with PCOS in child bearing age who presented at reproductive and endocrinology clinics at Ain Shams University Maternity Hospital

You may qualify if:

  • Females with PCOS in child bearing age who presented at reproductive and endocrinology clinics at Ain Shams University Maternity Hospital

You may not qualify if:

  • Known androgen secreting tumor.
  • PCO on ovarian stimulation medications
  • PCO with any other medical illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Kotb

Cairo, Cairo Governorate, Egypt

Location

Biospecimen

Retention: SAMPLES WITH 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 Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in obstertics and gynecology, Ain Shams University Hospital

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 17, 2016

Study Start

November 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

October 2, 2018

Record last verified: 2018-02

Locations

EG(1)