New Device to Maintain the Embryo Temperature During Transfer

Embryo Transfer Clinical Trial

— EmbryoTemp  

Official title:

A New System for Preventing Thermal Stress During Embryo Transfer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02650310
• Other study ID #: Instituto Bernabeu Group
• Status: Recruiting
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2019

Study information

• Verified date: August 2019
• Source: Instituto Bernabeu
• Contact: Jorge Ten Morro, Ph.D.
• Phone: 696914882
• Email: jten[@]institutobernabeu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The embryo transfer implies transportation from the incubator where they have been at 37 ° C, to the transfer catheter inside a laminar flow hood whose working surface is also maintained at 37 ° C. . From the laboratory to the operating room the embryo is exposed to a temperature drop, and consequently thermal stress occurs, which may compromise its future viability.

The aim of this study is to assess the possible improvement in the clinical results when the embryos are transported in a stable device to avoid the drop in temperature throughout the transfer process.

With the use of this thermosetting device heated to 37 ° C, researchers expect a 15% increase in pregnancy rates.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 352
• Est. completion date: December 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Cryo-transfer cycles: transfer of embryos vitrified in previous cycles receiving donated eggs inseminated with either conjugal or donated sperm from Instituto Bernabeu bank.

Exclusion Criteria:

• Fresh cycles: transfer of fresh embryos (coming from donated or own eggs), and cryo-transfer cycles from vitrified embryos coming from own oocytes.

Related Conditions & MeSH terms

• Embryo Transfer

Intervention

Device:
• Thermostable device
Investigators place the catheter with the loaded embryos into a plastic device at 37ºC in order to maintain the temperature

Locations

Country	Name	City	State
Spain	Instituto Bernabeu	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Rafael Bernabeu Pérez

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing Pregnancy rate	Achieving an ongoing pregnancy after embryo transfer	Ongoing pregnancy until 28th week of gestation
Secondary	Miscarriage rate	To know the embryonic loss rate after implantation	Loss of pregnancy up to 12 weeks of gestation
Secondary	Implantation rate	To know the embryo implantation rate after the embryo transfer	Embryo implantation after 6-7 weeks of gestation