Clinical trial NCT03519763: Intrauterine Microbiota During IVF in Patients Affected With Isthmocele.
Official title: Endometrial and Isthmic Microbiota During IVF Stimulation in Patients Affected With Isthmocele and Intrauterine Mucus Secretion After C-section.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Diseases
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients undergoing IVF treatment.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: If the intrauterine microbiota profile in patients affected with isthmocele differs from the one found in patients without isthmocele.
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: IVI Middle East Fertilty Clinic
Study officials:
affiliation: Medical Director
name: Human Fatemi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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