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OpenTrials
Completed

NCT Number: NCT03519763

Intrauterine Microbiota During IVF in Patients Affected With Isthmocele.

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.

Completed

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

IVI Middle East Fertilty Clinic

Abu Dhabi, United Arab Emirates

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound

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.

Other names: transvaginal scan, ultrasound

Primary outcomes

  1. If the intrauterine microbiota profile in patients affected with isthmocele differs from the one found in patients without isthmocele.

    Time frame: 1year

    patients undergoing in vitro fertilization treatment

Sponsors and collaborators

Lead sponsor

ART Fertility Clinics LLC

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
May 9, 2018
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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