New Device to Maintain the Embryo Temperature During Transfer (EmbryoTemp)

A New System for Preventing Thermal Stress During Embryo Transfer

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.

Study Overview

• Status: Unknown
• Conditions: Embryo Transfer
• Intervention / Treatment: Device: Thermostable device

• Study Type: Interventional
• Enrollment (Anticipated): 352
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03016
    • Recruiting
    • Instituto Bernabeu
    • Contact: Rafael Bernabeu, M.D., Ph.D.; Phone Number: +34965154000; Email: rbernabeu@institutobernabeu.com
    • Contact: Rafael Bernabeu, M.D., Ph.D; Phone Number: +34965154000; Email: rbernabeu@institutobernabeu.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional transfer; This arm is the control group (conventional embryo transfer protocol) where there is no intervention.
Experimental: Thermostable device transfer; This arm is the study group: embryo transfer protocol using a new thermostable device.	Device: Thermostable device; Investigators place the catheter with the loaded embryos into a plastic device at 37ºC in order to maintain the temperature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ongoing Pregnancy rate	Achieving an ongoing pregnancy after embryo transfer	Ongoing pregnancy until 28th week of gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Miscarriage rate	To know the embryonic loss rate after implantation	Loss of pregnancy up to 12 weeks of gestation
Implantation rate	To know the embryo implantation rate after the embryo transfer	Embryo implantation after 6-7 weeks of gestation

Collaborators and Investigators

• Sponsor: Rafael Bernabeu Pérez

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): March 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: January 7, 2016
• First Posted (Estimate): January 8, 2016

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Instituto Bernabeu Group