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Intrauterine Microbiota During IVF in Patients Affected With Isthmocele.

Sponsor
ART Fertility Clinics LLC (Other)
Overall Status
Completed
CT.gov ID
NCT03519763
Collaborator
(none)
3
Enrollment
1
Location
20.4
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ultrasound

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 Design

Study Type:
Observational
Actual Enrollment :
3 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Endometrial and Isthmic Microbiota During IVF Stimulation in Patients Affected With Isthmocele and Intrauterine Mucus Secretion After C-section.
Actual Study Start Date :
Jun 13, 2018
Actual Primary Completion Date :
Nov 30, 2019
Actual Study Completion Date :
Feb 24, 2020

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. If the intrauterine microbiota profile in patients affected with isthmocele differs from the one found in patients without isthmocele. [1year]

      patients undergoing in vitro fertilization treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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).

    1. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IVI Middle East Fertilty Clinic Abu Dhabi United Arab Emirates

    Sponsors and Collaborators

    • ART Fertility Clinics LLC

    Investigators

    • Principal Investigator: Human Fatemi, MD, Medical Director

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Prof Dr. Human Fatemi, Principal Investigator, ART Fertility Clinics LLC
    ClinicalTrials.gov Identifier:
    NCT03519763
    Other Study ID Numbers:
    • 1707-ABU-065-HF
    First Posted:
    May 9, 2018
    Last Update Posted:
    Feb 25, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Uterine Diseases

    Study Results

    No Results Posted as of Feb 25, 2020