The Effect of Obesity on Endometrium in PCOS

NCT ID: NCT02694419

Last Updated: 2017-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Body Weight Polycystic Ovary Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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obese/PCO

Women with PCOS who are overweight\\obese with BMI ≥ 25 kg/m2.

Doppler evaluation

Intervention Type DEVICE

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.

Doppler evaluation

Intervention Type DEVICE

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.

Doppler evaluation

Intervention Type DEVICE

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.

Doppler evaluation

Intervention Type DEVICE

Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler

Interventions

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Doppler evaluation

Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmed Abbas

Assiut, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PCOS

Identifier Type: -

Identifier Source: org_study_id

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