Does the Air-bubble Location Influence on the Implantation Rate (TRANSFER)

Evaluation of the Implantation Rate Depending on the Air Bubble Location Through Ultrasound Into the Uterine Cavity in Pre-embryo Transfer

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.

Study Overview

• Status: Completed
• Conditions: Embryo Disorder
• Intervention / Treatment: Other: Collect retrospectively data on embryo implantation rate

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 Type: Observational
• Enrollment (Actual): 400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

IVIVigo patients with a normal uterine anatomy and a single good quality embryo to transfer at blastocyst stage, performed by the same gynaecologist using the "three-drop technique" were included. All transfer were atraumatic, without blood presence, using soft catheter and with controlled ultrasound transfer. The distance between the fundus surface and the tip of catheter, the distance between the fundus and the air bubble, the endometrial thickness and the implantation rate were recorded.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Frozen embryo transfer (FET); Collect retrospectively data on embryo implantation rate	Other: Collect retrospectively data on embryo implantation rate; Collect retrospectively data on embryo implantation rate
Intracytoplasmic sperm injection (ICSI); Collect retrospectively data on embryo implantation rate
oocyte donation; Collect retrospectively data on embryo implantation rate	Other: Collect retrospectively data on embryo implantation rate; Collect retrospectively data on embryo implantation rate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implantation rate	Analyze Implantation rate in the groups	Since September 2013 October 2019

Collaborators and Investigators

• Sponsor: IVI Vigo

Publications and helpful links

General Publications

• Friedman BE, Lathi RB, Henne MB, Fisher SL, Milki AA. The effect of air bubble position after blastocyst transfer on pregnancy rates in IVF cycles. Fertil Steril. 2011 Mar 1;95(3):944-7. doi: 10.1016/j.fertnstert.2010.07.1063.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 20, 2013
• Primary Completion (ACTUAL): October 25, 2019
• Study Completion (ACTUAL): October 25, 2019

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (ACTUAL): October 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: pregnancy; embryo
• Other Study ID Numbers: 1607-VGO-056-EM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No