Intrauterine Microbiota During IVF in Patients Affected With Isthmocele.

Completed

• Conditions: Endometrial Diseases
• Interventions: Diagnostic Test: ultrasound

• Registration Number: NCT03519763
• Lead Sponsor: ART Fertility Clinics LLC

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.

Study Timeline

• Study First Submitted: 2018-04-25
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-09
• Study Start: 2018-06-13
• Primary Completion: 2019-11-30
• Status Verified: 2020-02
• Study Completion: 2020-02-24
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study subgroup2	ultrasound	15 patients with 2 or more previous C-Section.
Control group	ultrasound	Fifteen patients without isthmocele

Primary Outcome Measures

Name	Time	Method
If the intrauterine microbiota profile in patients affected with isthmocele differs from the one found in patients without isthmocele.	1year	patients undergoing in vitro fertilization treatment

Trial Locations

Locations (1)

IVI Middle East Fertilty Clinic; 🇦🇪 Abu Dhabi, United Arab Emirates