CClinicalTrials.gg
CompletedNCT02694419OB-PCOUpdated Aug 11, 2017

The Effect of Obesity on Endometrium in PCOS

An observational study in Body Weight and Polycystic Ovary Syndrome, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-08-11.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Body Weight
  • Polycystic Ovary Syndrome

Keywords

  • endometrium
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's enrollment of 100 is below the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

100 women were recruited from gynecology clinic of Women Health Hospital

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • obese/PCO

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

    Device: Doppler evaluation

  • normal weight/PCO

    Women with PCOS who are normal weight with BMI \< 25 kg/m2.

    Device: Doppler evaluation

  • 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

  • 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

Interventions

  • DeviceDoppler evaluation

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

06

What researchers measure

Primary outcomes

  1. the mean difference in Doppler indices (VI-FI-VFI)

    Time frame: 24 hours

07

Study locations

1 site
  • Ahmed Abbas
    Assiut, Cairo 002, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02694419
Lead sponsor
Assiut University
Responsible party
Ahmed Mohamed Abbas (Dr, Assiut University) — Principal investigator
First posted
Feb 29, 2016
Start date
Feb 2016
Primary completion
Dec 2016
Completion
Apr 2017
Last update
Aug 11, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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