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Intrauterine Microbiota During IVF in Patients Affected With Isthmocele.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03519763
Enrollment
3
Registered
2018-05-09
Start date
2018-06-13
Completion date
2020-02-24
Last updated
2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Diseases

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.

Interventions

DIAGNOSTIC_TESTultrasound

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

Sponsors

ART Fertility Clinics LLC
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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). 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.

Design outcomes

Primary

MeasureTime frameDescription
If the intrauterine microbiota profile in patients affected with isthmocele differs from the one found in patients without isthmocele.1yearpatients undergoing in vitro fertilization treatment

Countries

United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026