Intrauterine Microbiota During IVF in Patients Affected With Isthmocele.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-13

Study Completion Date

2020-02-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Endometrial Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

Fifteen patients without isthmocele

ultrasound

Intervention Type DIAGNOSTIC_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.

Study subgroup1

15 patients with 1 previous C-Section

No interventions assigned to this group

Study subgroup2

15 patients with 2 or more previous C-Section.

ultrasound

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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transvaginal scan, ultrasound

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes