The Effect of Obesity on Endometrium in PCOS

Polycystic Ovary Syndrome Clinical Trial

— OB-PCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694419
• Other study ID #: PCOS
• Status: Completed
• Phase: N/A
• First received: February 24, 2016
• Last updated: August 10, 2017
• Start date: February 2016
• Est. completion date: April 2017

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Device:
• Doppler evaluation
Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler

Locations

Country	Name	City	State
Egypt	Ahmed Abbas	Assiut	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the mean difference in Doppler indices (VI-FI-VFI)		24 hours