The Effect of Obesity on Endometrium in PCOS (OB-PCO)

August 10, 2017 updated by: Ahmed Mohamed Abbas, Assiut University

Effect of Body Weight on Endometrial Ultrasonographic Characteristics in Polycystic Ovary Syndrome Patients

The effect of Polycystic Ovary Syndrome (PCOS) with or without obesity has received a few attentions. There is a lack of evidence to whether the BMI affects the endometrial blood flow, which is necessary for implantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo
      • Assiut, Cairo, Egypt, 002
        • Ahmed Abbas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

100 women were recruited from gynecology clinic of Women Health Hospital

Description

Inclusion Criteria:

  • Women with PCOS are diagnosed according to Rotterdam criteria, (Rotterdam and ASRM-Sponsored, 2004)by the presence of two out of the following three: oligomenorrhea (absence of menses for 35-182 days) or amenorrhea (absence of menses for >182 days), signs or symptoms of hyperandrogenism (acne, hirsutism), US showing polycystic ovaries.
  • Fertile women had regular menstruation, with at least one previous spontaneous pregnancy.

Exclusion Criteria:

  • Women known to have hepatic or renal dysfunction, Diabetes mellitus, hypertension, or cardiovascular disease.
  • If they have used induction of ovulation drugs for the last three months.
  • If they have used hormonal contraception in the last three months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
obese/PCO
Women with PCOS who are overweight\obese with BMI ≥ 25 kg/m2.
Device: Doppler evaluation
Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler
normal weight/PCO
Women with PCOS who are normal weight with BMI < 25 kg/m2.
Device: Doppler evaluation
Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler
Obese/fertile
Fertile regularly menstruating women with at least one previous spontaneous pregnancy who are overweight\obese with BMI ≥ 25 kg/m2.
Device: Doppler evaluation
Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler
normal weight/fertile
Fertile regularly menstruating women with at least one previous spontaneous pregnancy who are normal weight with BMI < 25 kg/m2.
Device: Doppler evaluation
Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the mean difference in Doppler indices (VI-FI-VFI)
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

February 26, 2016

First Posted (Estimate)

February 29, 2016

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 10, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pcos

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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