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CompletedNCT04574310TRANSFERUpdated Oct 6, 2020

Does the Air-bubble Location Influence on the Implantation Rate

An observational study in Embryo Disorder, sponsored by IVI Vigo. Completed. Open to female participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-10-06.

Sponsored by IVI Vigo · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
400
Ages
30 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Embryo Disorder

Keywords

  • embryo
  • pregnancy
03

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
400 participants (actual)
Patient registry
No

Groups and cohorts

  • Frozen embryo transfer (FET)

    Collect retrospectively data on embryo implantation rate

    Other: 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

Interventions

  • OtherCollect retrospectively data on embryo implantation rate

    Collect retrospectively data on embryo implantation rate

05

What researchers measure

Primary outcomes

  1. Implantation rate

    Analyze Implantation rate in the groups

    Time frame: Since September 2013 October 2019

06

Study locations

No study locations are listed for this record.

07

References and documents

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. PubMed 20810105 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04574310
Lead sponsor
IVI Vigo
Responsible party
Sponsor
First posted
Oct 5, 2020
Start date
Sep 20, 2013
Primary completion
Oct 25, 2019
Completion
Oct 25, 2019
Last update
Oct 6, 2020

Study contacts

Ekin DR Muñoz, MD
principal investigator · IVI Vigo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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