The Effect of Obesity on Endometrium in PCOS

Completed

• Conditions: Body Weight; Polycystic Ovary Syndrome
• Interventions: Device: Doppler evaluation

• Registration Number: NCT02694419
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-24
• Study First Submitted QC: 2016-02-26
• Study First Posted: 2016-02-29
• Primary Completion: 2016-12
• Study Completion: 2017-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-10
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
normal weight/fertile	Doppler evaluation	Fertile regularly menstruating women with at least one previous spontaneous pregnancy who are normal weight with BMI \< 25 kg/m2.
Obese/fertile	Doppler evaluation	Fertile regularly menstruating women with at least one previous spontaneous pregnancy who are overweight\\obese with BMI ≥ 25 kg/m2.
obese/PCO	Doppler evaluation	Women with PCOS who are overweight\\obese with BMI ≥ 25 kg/m2.
normal weight/PCO	Doppler evaluation	Women with PCOS who are normal weight with BMI \< 25 kg/m2.

Primary Outcome Measures

Name	Time	Method
the mean difference in Doppler indices (VI-FI-VFI)	24 hours

Trial Locations

Locations (1)

Ahmed Abbas; 🇪🇬 Assiut, Cairo, Egypt