Septum; UterusNCT03792438

Study of the Vascularity of Uterine Septum Using Three Dimensional Power Doppler Ultrasound

An observational study of Septum; Uterus, run by Ain Shams Maternity Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study aims to assess the relation between the vascularity of uterine septum and obstetric performance with Transvaginal 3D Power Doppler Ultrasound Read more about this study

Who is it for?: Ages 18 to 35 years, women only
Conditions the study is for: Septum; Uterus
What is being tested?: Transvaginal 3D Power Doppler Ultrasound
How many people: 30 participants
Where: 1 siteEgypt
Study dates: 27 May 2017to 25 Nov 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
Women only
No healthy volunteers
Adult

Study population: Patients with primary infertility or recurrent abortion attending to Early Cancer Detection Unit at Ain Shams Maternity Hospital

Who may be able to join

Patients with septate uterus diagnosed by office hysteroscopy

Who cannot join

Women with previous uterine scar.
Women with suspected or confirmed pregnancy.
Women with active pelvic infection or old one.
Women with abnormal uterine bleeding.
Fibroids, adenomyosis or ovarian swelling.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Ain Shams University Maternity Hospital
Cairo, 11357

Other trials in Egypt

About this study

This study aims to assess the relation between the vascularity of uterine septum and obstetric performance with Transvaginal 3D Power Doppler Ultrasound

Read the detailed description

Research hypothesis:

In women with uterine septum vascularity of the septum may affect obstetric performance.

Research question:

In women with uterine septum does vascularity of the septum affect obstetric outcome?

Conditions: Septum; Uterus
Being tested: Transvaginal 3D Power Doppler Ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transvaginal 3D Power Doppler UltrasoundDiagnostic test
Samsung H60 ultrasound machine with 4-9 MHz volume transducer using VOCAL system and Histogram Facility

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with high vascular indices (VI, FI, VFI) in relation to Vascular indices of the rest of the surrounding myometrium
Number of participants with high vascular indices (VI, FI, VFI) in relation to Vascular indices of the rest of the surrounding myometrium and its relationship to either primary infertility or recurrent abortion
Measured: About 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 May 201725 Nov 2018

First posted3 Jan 2019
Study start27 May 2017
Primary completion25 Nov 2018
Study completion25 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Septum; UterusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03792438
Sponsor's protocol ID: Hesham Mohamed Elnaggar
Status last verified: Jan 2019
First submitted: 26 Dec 2018
Last updated: 3 Jan 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Intrauterine Stent Placement Following Hysteroscopic Septum Resection
Intrauterine Adhesion
Recruiting
Surgical Approach to Uterine Septum
Uterine Septum, Surgical Complication
Recruiting
A Multicenter, Prospective, Randomized Controlled Clinical Study on the Effect of Hysteroscopic Uterine Septum Resection on IVF-ET Outcomes in Infertile Patients With Non-recurrent Miscarriage
Infertility and Miscarriage
Recruiting
Added Value of Three-dimensional Transvaginal Ultrasound (3D TVUS) and Gel Infusion Sonography (3D GIS) Compared With Magnetic Resonance Imaging (MRI) in the Diagnosis of Patients With Suspicion of a Uterine Septum.
Uterine Septum
Recruiting
A Multicenter, Prospective, Randomized, Controlled Clinical Study on the Effect of Hysteroscopic Uterine Septum Resection on the Natural Pregnancy Outcomes in Patients With Non-recurrent Spontaneous Abortion
Infertility and Miscarriage

All Septum; Uterus trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Vascularity of Uterine Septum Using Three Dimensional Power Doppler Ultrasound
ClinicalTrials.gov ID: NCT03792438
Acronym / sponsor ID: Hesham Mohamed Elnaggar
Conditions: Septum; Uterus
Study type: Observational
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Ain Shams Maternity HospitalUniversity, hospital or other
Study start: 27 May 2017 (actual)
Primary completion: 25 Nov 2018 (actual)
Study completion: 25 Nov 2018 (actual)
First posted: 3 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study aims to assess the relation between the vascularity of uterine septum and obstetric performance with Transvaginal 3D Power Doppler Ultrasound

Detailed description

Research hypothesis:

In women with uterine septum vascularity of the septum may affect obstetric performance.

Research question:

In women with uterine septum does vascularity of the septum affect obstetric outcome?

Study design

Observational model: Cohort
Time perspective: Cross-sectional

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult
Study population: Patients with primary infertility or recurrent abortion attending to Early Cancer Detection Unit at Ain Shams Maternity Hospital

Key inclusion criteria (1 listed)

Patients with septate uterus diagnosed by office hysteroscopy

Key exclusion criteria (5 listed)

Women with previous uterine scar.
Women with suspected or confirmed pregnancy.
Women with active pelvic infection or old one.
Women with abnormal uterine bleeding.
Fibroids, adenomyosis or ovarian swelling.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transvaginal 3D Power Doppler UltrasoundSamsung H60 ultrasound machine with 4-9 MHz volume transducer using VOCAL system and Histogram Facility	Diagnostic test	–

Primary outcome

Number of participants with high vascular indices (VI, FI, VFI) in relation to Vascular indices of the rest of the surrounding myometrium
Time frame: About 18 months
Number of participants with high vascular indices (VI, FI, VFI) in relation to Vascular indices of the rest of the surrounding myometrium and its relationship to either primary infertility or recurrent abortion

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
Individual participant dataSharing planned: No

Related trials for Septum; Uterus

Recruiting
Intrauterine Stent Placement Following Hysteroscopic Septum Resection
Intrauterine Adhesion
Recruiting
Surgical Approach to Uterine Septum
Uterine Septum, Surgical Complication
Recruiting
A Multicenter, Prospective, Randomized Controlled Clinical Study on the Effect of Hysteroscopic Uterine Septum Resection on IVF-ET Outcomes in Infertile Patients With Non-recurrent Miscarriage
Infertility and Miscarriage
Recruiting
Added Value of Three-dimensional Transvaginal Ultrasound (3D TVUS) and Gel Infusion Sonography (3D GIS) Compared With Magnetic Resonance Imaging (MRI) in the Diagnosis of Patients With Suspicion of a Uterine Septum.
Uterine Septum
Recruiting
A Multicenter, Prospective, Randomized, Controlled Clinical Study on the Effect of Hysteroscopic Uterine Septum Resection on the Natural Pregnancy Outcomes in Patients With Non-recurrent Spontaneous Abortion
Infertility and Miscarriage

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mohamed I Amer, MD study chair

Professor

Nashwa E Hassan, MD study director

Assistant Professor

Mortada E Ahmed, MD study director

Lecturer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Septum; Uterus, run by Ain Shams Maternity Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with high vascular indices (VI, FI, VFI) in relation to Vascular indices of the rest of the surrounding myometrium (time frame: About 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03792438.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.