NCT03397693

Brief Summary

Evaluation of the endometrial thickness and subendometrial blood perfusion in women with unexplained infertility and PCOS using 3D Power Doppler and uterine artery Doppler in comparison to a control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 3, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

January 3, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2019

Completed
Last Updated

July 2, 2019

Status Verified

June 1, 2019

Enrollment Period

1.3 years

First QC Date

January 3, 2018

Last Update Submit

June 30, 2019

Conditions

Unexplained InfertilityPCOSEndometrial Thickness

Keywords

PCOSUnexplained infertiltiy3D Power DopplerEndometrial thicknessSubendometrial blood perfusion

Outcome Measures

Primary Outcomes (3)

  • Endometrial thickness

    Thickest part of the endometrium in sagittal plane by transvaginal ultrasound

    Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient

  • Endometrial and sub-endometrial blood perfusion expressed as VI, FI VFI.

    Endometrial and sub-endometrial blood perfusion by 3D Power Doppler

    Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient

  • 2D Doppler indices of both uterine arteries

    RI, PI of uterine arteries.

    Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient

Secondary Outcomes (3)

  • Demographic characteristics of included women.

    Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient

  • Endometrial volume

    Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient

  • Uterine volume

    Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient

Study Arms (3)

1

Women with unexplained infertiltiy with no treatment given

2

Women with Poly Cystic Ovary Syndrome (PCOS) who are not being treated with drugs of ovulation induction.

3

Control fertile women with no treatment given.

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

1. unexplained infertility (normal regular menstrual cycles and normal pelvic examination, evidence of ovulation by TV/US and normal mid-luteal serum progesterone, normal semen analysis of the husband according to WHO guidlines2010 (25), and evidence of tubal patency and normal uterine cavity by HSG and/or laparoscopy). 2. Women with PCOS according to Rotterdam ASRM/ESHRE criteria(26) 3. Healthy fertile women (Multipara with last delivery since ≥ 2 years with no history of abortions and not on contraception (hormonal or IUD)).

You may qualify if:

  • Women with primary or secondary infertility for more than 1 year due to unexplained infertility (normal regular menstrual cycles and normal pelvic examination, evidence of ovulation by TV/US and/or normal mid-luteal serum progesterone, normal semen analysis of the husband according to WHO guidlines2010 (25), and evidence of tubal patency and normal uterine cavity by HSG and/or laparoscopy).
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  • Women with no history of menstrual dysfunction or subfertility.
  • Normal regular cycles and normal pelvic examination.
  • Multipara with last delivery since ≥ 2 years with no history of abortions and not on contraception (hormonal or IUD).

You may not qualify if:

  • History of pelvic surgery or pelvic inflammatory disease.
  • Current hormonal contraception.
  • On IUD.
  • History of or clinical features suggesting endometriosis or pelvic pathology like uterine fibroid and ovarian cyst.
  • General medical disorders (e.g. D.M), smoking and lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, School of Medicine, Assiut University

Asyut, 71500, Egypt

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Moustafa Gadalla, Assistant lecturer and specialist of obstetrics and gynecology in school of medicine in Assiut University in Egypt

Study Record Dates

First Submitted

January 3, 2018

First Posted

January 12, 2018

Study Start

January 3, 2018

Primary Completion

April 20, 2019

Study Completion

May 20, 2019

Last Updated

July 2, 2019

Record last verified: 2019-06

Locations

EG(1)