Intrauterine Microbiota During IVF in Patients Affected With Isthmocele.

February 24, 2020 updated by: Prof Dr. Human Fatemi, ART Fertility Clinics LLC

Endometrial and Isthmic Microbiota During IVF Stimulation in Patients Affected With Isthmocele and Intrauterine Mucus Secretion After C-section.

To evaluate the endometrial and isthmic microbiota in patients with isthmocele after C-Section, and if this microbiota is similar or not with better reproductive outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 45 subjects undergoing in vitro fertilization treatment. Fifteen patients without isthmocele will be included in the control group and 30 patients affected with isthmocele in the other group, divided in 2 subgroups: 15 with 1 previous C-Section, and 15 with 2 or more previous C-Section. Paired samples of endometrial fluid (EF) and isthmic fluid (IF) will be obtained simultaneously the day of egg retrieval. Patients will follow a protocol for all-freezing embryos or oocytes.

Study Type

Observational

Enrollment (Actual)

3

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female patients undergoing IVF treatment.

Description

Inclusion Criteria:

  1. Patients with isthmocele:

    • Patients performing IVF treatment with a planned cycle segmentation and consecutive frozen embryo transfer on a hormone replacement therapy (HRT) cycle or natural cycle.
    • Age between 18 - 45 years all (both inclusive).
    • One or multiple C-sections.
    • Isthmocele present during TV scan.
    • BMI: 18,5 - 35 kg / m2 (both inclusive).

  2. Patients without isthmocele:

    • Patients performing IVF treatment with planned cycle segmentation and who would have embryo transfer with frozen embryos under hormone replacement therapy.
    • NO Isthmocele present during transvaginal ultrasound.
    • BMI: 18,5 - 30 kg / m2 (both inclusive).

Exclusion Criteria:

  • Age < 18 and > 45 years old.
  • Previous or active endometritis.
  • Patients who are IUD carriers for the last 3 months.
  • Patients who have taken prescribed antibiotics in the last 3 months previous to sample collection.

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
Control group
Fifteen patients without isthmocele
Diagnostic test: ultrasound
All the patients will have a transvaginal ultrasound evaluation during the first visit to the clinic to evaluate the presence or not of isthmocele.
Other Names:
  • transvaginal scan, ultrasound
Study subgroup1
15 patients with 1 previous C-Section
Study subgroup2
15 patients with 2 or more previous C-Section.
Diagnostic test: ultrasound
All the patients will have a transvaginal ultrasound evaluation during the first visit to the clinic to evaluate the presence or not of isthmocele.
Other Names:
  • transvaginal scan, ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
If the intrauterine microbiota profile in patients affected with isthmocele differs from the one found in patients without isthmocele.
Time Frame: 1year
patients undergoing in vitro fertilization treatment
1year

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, Medical Director

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

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 13, 2018

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

February 24, 2020

Study Registration Dates

First Submitted

April 25, 2018

First Submitted That Met QC Criteria

May 8, 2018

First Posted (Actual)

May 9, 2018

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 24, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1707-ABU-065-HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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