The Effect of Obesity on Endometrium in PCOS
OB-PCO
Effect of Body Weight on Endometrial Ultrasonographic Characteristics in Polycystic Ovary Syndrome Patients
1 other identifier
observational
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 24, 2016
CompletedFirst Posted
Study publicly available on registry
February 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedAugust 11, 2017
August 1, 2017
10 months
February 24, 2016
August 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the mean difference in Doppler indices (VI-FI-VFI)
24 hours
Study Arms (4)
obese/PCO
Women with PCOS who are overweight\\obese with BMI ≥ 25 kg/m2.
normal weight/PCO
Women with PCOS who are normal weight with BMI \< 25 kg/m2.
Obese/fertile
Fertile regularly menstruating women with at least one previous spontaneous pregnancy who are overweight\\obese with BMI ≥ 25 kg/m2.
normal weight/fertile
Fertile regularly menstruating women with at least one previous spontaneous pregnancy who are normal weight with BMI \< 25 kg/m2.
Interventions
Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler
Eligibility Criteria
100 women were recruited from gynecology clinic of Women Health Hospital
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ahmed Abbas
Assiut, Cairo Governorate, 002, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
February 24, 2016
First Posted
February 29, 2016
Study Start
February 1, 2016
Primary Completion
December 1, 2016
Study Completion
April 1, 2017
Last Updated
August 11, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share