Intrauterine Microbiota During IVF in Patients Affected With Isthmocele.

Study Overview
=================
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.

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.

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

Conditions
-----------------
Endometrial Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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). 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>Fifteen patients without isthmocele | Diagnostic Test: ultrasound<br>* All the patients will have a transvaginal ultrasound evaluation during the first visit to the clinic to evaluate the presence or not of isthmocele.<br>* Other names: transvaginal scan, ultrasound;|
| Study subgroup1<br>15 patients with 1 previous C-Section | |
| Study subgroup2<br>15 patients with 2 or more previous C-Section. | Diagnostic Test: ultrasound<br>* All the patients will have a transvaginal ultrasound evaluation during the first visit to the clinic to evaluate the presence or not of isthmocele.<br>* 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. | patients undergoing in vitro fertilization treatment | 1year |