Does the Air-bubble Location Influence on the Implantation Rate

Completed

• Conditions: Embryo Disorder
• Interventions: Other: Collect retrospectively data on embryo implantation rate

• Registration Number: NCT04574310
• Lead Sponsor: IVI Vigo

Brief Summary

The main objective of the study is to evaluate whether there is any association between the location into the uterine cavity, where the air bubbles containing the pre-embryos were placed, and the implantation rate. Therefore, the images generated during pre-embryos transfer are available in our database and studied retrospectively.

Detailed Description

The success of a reproductive treatment is determined by three variables: the pre-embryo quality, endometrial receptiveness and pre-embryo transfer. Several previous studies show a lack of agreement concerning the greatest measurement. For instance, some of them refer to the distance between the catheter and the uterine fundus, whereas some others take as a reference the air-bubble where the pre-embryos were placed.

It is for this reason that in the present study, we aim to evaluate the air bubble location ratio into the uterine cavity with reproductive success, taking into account the different variables to reach success. That is, embryo characteristics (quality, development day) endometrium preparation (cycle type, hormone levels on day 5) and even the transfer procedure (type of catheter, blood, difficulty channeling).

It is a study that aims to collect data from January 2013 to october 2019. To this end, the images generated during pre-embryos transfer are analyzed retrospectively. Therefore, it is evaluated the existing differences on implantation rate according to air-bubble placement into uterine cavity during the transfer procedure.

Study Timeline

• Study Start: 2013-09-20
• Primary Completion: 2019-10-25
• Study Completion: 2019-10-25
• Study First Submitted: 2020-09-28
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-01
• Last Update Submitted: 2020-10-02
• Study First Posted: 2020-10-05
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• Patients with normal uterine anatomy, who underwent an ultrasound guided embryo transfer.
• BMI< 30kg/m2.
• Ultrasound guided embryo transfer made by the same researcher.

Exclusion Criteria

• Presence of uterine fibroid in the anterior uterine body that make difficult the transfer visualization.
• Asherman Syndrome.
• Adenomyosis that reduces the uterine cavity visibility.
• Difficult transfers where the use of a semi-rigid cannula sheath is needed to entry into the uterine cavity.
• Previous uterine surgery that alters its anatomy.
• Istmocele

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
oocyte donation	Collect retrospectively data on embryo implantation rate	Collect retrospectively data on embryo implantation rate
Frozen embryo transfer (FET)	Collect retrospectively data on embryo implantation rate	Collect retrospectively data on embryo implantation rate

Primary Outcome Measures

Name	Time	Method
Implantation rate	Since September 2013 October 2019	Analyze Implantation rate in the groups