Intracavitary Fluid and Position of C-section-scar

August 6, 2019 updated by: Barbara Lawrenz, ART Fertility Clinics LLC

Does the Presence of Intracavitary Fluid During Hormonal Stimulation for IVF Depends on the Position of C-section-scar?

Does the presence of intracavitary fluid during hormonal stimulation for IVF depends on the position of C-section-scar ?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To evaluate the correlation between the presence of intracavitary fluid and the position of the C-section-scar in relation to the uterine fundus and the inner cervical os.

To this end, we will compare measured variables, in patients with intracavitary fluid and without intracavitary fluid.

Study Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing IVF treatment in the IVI Middle East Clinic Abu Dhabi and Dubai, due to secondary infertility and delivery with at least one previous C-section.

Description

Inclusion Criteria:

  • Patients above an age of 18 years.
  • Patients performing IVF treatment.
  • One or multiple C-sections.
  • C-scar region visible during trans-vaginal scan.

Exclusion Criteria:

  • Patients who were IUD carriers in the last 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with intracavitary fluid
to evaluate the correlation between the presence of intracavitary fluid during hormonal stimulation for IVF depending on the position of C-section-scar and the presence of an isthmocele, this group patients will have intracavitary fluid.
Diagnostic test: ultrasound,transvaginal scan
The presence of fluid in the uterine cavity during hormonal stimulation.
Patients without intracavitary fluid
to evaluate the correlation between the presence of intracavitary fluid during hormonal stimulation for IVF depending on the position of C-section-scar and the presence of an isthmocele, in this group patients will not have intracavitary fluid.
Diagnostic test: ultrasound,transvaginal scan
The presence of fluid in the uterine cavity during hormonal stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence/Absence of ICF
Time Frame: 1 year and 6 months
to evaluate the correlation between the presence of intracavitary fluid and the position of the C-section-scar in relation to the inner cervical os, during hormonal stimulation for IVF.
1 year and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thickness of fluid accumulation in the cavity
Time Frame: 1 year and 6 months
Presence or Absence of ICF
1 year and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ART Fertility Clinics LLC

Investigators

  • Principal Investigator: Human Fatemi, MD, ART Fertility Clinics LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2018

Primary Completion (Actual)

March 13, 2019

Study Completion (Actual)

July 17, 2019

Study Registration Dates

First Submitted

April 25, 2018

First Submitted That Met QC Criteria

April 25, 2018

First Posted (Actual)

May 8, 2018

Study Record Updates

Last Update Posted (Actual)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 1802-ABU-018-HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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