NCT04574310

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2013

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

6.1 years

First QC Date

September 28, 2020

Last Update Submit

October 2, 2020

Conditions

Keywords

embryopregnancy

Outcome Measures

Primary Outcomes (1)

  • Implantation rate

    Analyze Implantation rate in the groups

    Since September 2013 October 2019

Study Arms (3)

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

Collect retrospectively data on embryo implantation rate

Frozen embryo transfer (FET)oocyte donation

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 20810105BACKGROUND

Study Officials

  • Ekin DR Muñoz, MD

    IVI Vigo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 5, 2020

Study Start

September 20, 2013

Primary Completion

October 25, 2019

Study Completion

October 25, 2019

Last Updated

October 6, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share