Does the Air-bubble Location Influence on the Implantation Rate

Embryo Disorder Clinical Trial

— TRANSFER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04574310
• Other study ID #: 1607-VGO-056-EM
• Status: Completed
• Start date: September 20, 2013
• Est. completion date: October 25, 2019

Study information

• Verified date: October 2020
• Source: IVI Vigo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 25, 2019
• Est. primary completion date: October 25, 2019
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Embryo Disorder

Intervention

Other:
• Collect retrospectively data on embryo implantation rate
Collect retrospectively data on embryo implantation rate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IVI Vigo

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implantation rate	Analyze Implantation rate in the groups	Since September 2013 October 2019