Clinical trial NCT04574310: Does the Air-bubble Location Influence on the Implantation Rate
Official title: Evaluation of the Implantation Rate Depending on the Air Bubble Location Through Ultrasound Into the Uterine Cavity in Pre-embryo Transfer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Embryo Disorder
Keywords: embryo
pregnancy
Lead sponsor: IVI Vigo
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 400
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Implantation rate
timeFrame: Since September 2013 October 2019
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: IVI Vigo
name: Ekin DR Muñoz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.