Intrauterine Microbiota During IVF in Patients Affected With Isthmocele.

N/ACompletedNCT03519763

ART Fertility Clinics LLC3 enrolled

Overview

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.

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

Conditions

Endometrial Diseases

Interventions

ultrasoundDIAGNOSTIC_TEST

All the patients will have a transvaginal ultrasound evaluation during the first visit to the clinic to evaluate the presence or not of isthmocele.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

IVI Middle East Fertilty Clinic

Abu Dhabi, United Arab Emirates

Outcomes

Primary Outcomes

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

patients undergoing in vitro fertilization treatment

Time frame: 1year

Data from ClinicalTrials.gov

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