Intrauterine Microbiota During IVF in Patients Affected With Isthmocele.

A

ART Fertility Clinics LLC

Status

Completed

Conditions

Endometrial Diseases

Treatments

Diagnostic Test: ultrasound

Study type

Observational

Funder types

Other

Identifiers

NCT03519763
1707-ABU-065-HF

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

3 participants in 3 patient groups

Control group
Description:
Fifteen patients without isthmocele
Treatment:
Diagnostic Test: ultrasound
Study subgroup1
Description:
15 patients with 1 previous C-Section
Study subgroup2
Description:
15 patients with 2 or more previous C-Section.
Treatment:
Diagnostic Test: ultrasound

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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